Systems, methods, and devices to incentivize inhaler use

ABSTRACT

The present disclosure relates to systems, methods, and devices that may be used to incentivize inhaler use.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of the earliest availableeffective filing date(s) from the following listed application(s) (the“Priority Applications”), if any, listed below (e.g., claims earliestavailable priority dates for other than provisional patent applicationsor claims benefits under 35 USC §119(e) for provisional patentapplications, for any and all parent, grandparent, great-grandparent,etc. applications of the Priority Application(s)). In addition, thepresent application is related to the “Related Applications,” if any,listed below.

Priority Applications:

For purposes of the USPTO extra-statutory requirements, the presentapplication constitutes a continuation of U.S. patent application Ser.No. 14/459,075, entitled SYSTEMS, METHODS, AND DEVICES TO INCENTIVIZEINHALER USE, naming Jesse R. Cheatham, III, Roderick A. Hyde, Robert C.Petroski, Lowell L. Wood, Jr., and Victoria Y. H. Wood as inventors,filed 13 Aug. 2014, which is currently co-pending or is an applicationof which a currently co-pending application is entitled to the benefitof the filing date.

Related Applications:

For purposes of the USPTO extra-statutory requirements, the presentapplication is related to U.S. patent application Ser. No. [To BeAssigned], entitled SYSTEMS, METHODS, AND DEVICES TO INCENTIVIZE INHALERUSE, naming Jesse R. Cheatham, III, Roderick A. Hyde, Robert C.Petroski, Lowell L. Wood, Jr., and Victoria Y. H. Wood as inventors,filed Nov. 20, 2014, which is currently co-pending [Attorney Docket No.HS2-1082C2-US].

If the listings of applications provided above are inconsistent with thelistings provided via an ADS, it is the intent of the Applicant to claimpriority to each application that appears in the Priority Applicationssection of the ADS and to each application that appears in the PriorityApplications section of this application.

All subject matter of the Priority Applications and the RelatedApplications and of any and all parent, grandparent, great-grandparent,etc. applications of the Priority Applications and the RelatedApplications, including any priority claims, is incorporated herein byreference to the extent such subject matter is not inconsistentherewith.

If an Application Data Sheet (ADS) has been filed on the filing date ofthis application, it is incorporated by reference herein. Anyapplications claimed on the ADS for priority under 35 U.S.C. §§119, 120,121, or 365(c), and any and all parent, grandparent, great-grandparent,etc. applications of such applications, are also incorporated byreference, including any priority claims made in those applications andany material incorporated by reference, to the extent such subjectmatter is not inconsistent herewith.

SUMMARY

In one aspect, an inhaler includes, but is not limited to, a housinghaving at least one flow channel disposed therein; at least one portdisposed in the housing and operably coupled to the at least one flowchannel and configured to provide fluid communication between at leasttwo agent containing reservoirs and the at least one flow channel; oneor more sensors operably coupled with the at least one flow channel; atleast one actuator configured to independently facilitate at leastpartial release of at least one agent from each of at least two agentcontaining reservoirs when the at least two agent containing reservoirsare each operably coupled to the at least one port; and one or morecontrol units configured to receive information from the one or moresensors, wherein the one or more control units control operation of theat least one actuator in response to the information received from theone or more sensors. In some embodiments, an inhaler may optionallyinclude at least one reservoir. In some embodiments, an inhaler mayoptionally include one or more dose counters. In some embodiments, aninhaler may optionally include one or more performance indicators. Inaddition to the foregoing, other inhaler aspects are described in theclaims, drawings, and text forming a part of the present disclosure.

In one aspect, a method includes, but is not limited to, assessing oneor more parameters associated with use of an inhaler by a subject,administering at least one active agent to the subject in response toassessing the one or more parameters associated with use of the inhaler,and administering at least one incentive agent to the subject incoordination with administering the at least one active agent. In someembodiments, the method may optionally include displaying a comparisonof an assessed value associated with one or more respiration parameterswith one or more levels associated with the one or more respirationparameters. In some embodiments, the method may optionally includeinstructing the subject to achieve one or more values associated withone or more respiration parameters. In some embodiments, the method mayoptionally include accepting information associated with one or moreparameters associated with the subject. In some embodiments, the methodmay optionally include administering at least one additional agent tothe subject. In some embodiments, the method may optionally includeassessing one or more parameters associated with administering the atleast one active agent to the subject. In some embodiments, the methodmay optionally include assessing one or more parameters associated withadministering the at least one incentive agent to the subject. In someembodiments, the method may optionally include predicting one or morelocations in the pulmonary tract of the subject where the at least oneactive agent was delivered in response to the one or more parametersassociated with administration of the at least one active agent to thesubject. In some embodiments, the method may optionally includepredicting one or more locations in the pulmonary tract of the subjectwhere the at least one incentive agent was delivered in response to theone or more parameters associated with administration of the at leastone incentive agent to the subject. In addition to the foregoing, othermethod aspects are described in the claims, drawings, and text forming apart of the present disclosure.

In one aspect, a system includes, but is not limited to, circuitryconfigured to assess one or more parameters associated with use of aninhaler by a subject, circuitry configured to administer at least oneactive agent to the subject in response to assessing the one or moreparameters associated with use of the inhaler, and circuitry configuredto administer at least one incentive agent to the subject incoordination with administering the at least one active agent. In someembodiments, the system may optionally include circuitry configured todisplay a comparison of an assessed value associated with one or morerespiration parameters with one or more threshold levels associated withthe one or more respiration parameters. In some embodiments, the systemmay optionally include circuitry configured to instruct the subject toachieve one or more values associated with one or more respirationparameters. In some embodiments, the system may optionally includecircuitry configured to accept information associated with one or moreparameters associated with the subject. In some embodiments, the systemmay optionally include circuitry configured to assess one or moreparameters associated with administering the at least one active agentto the subject. In some embodiments, the system may optionally includecircuitry configured to assess one or more parameters associated withadministering the at least one incentive agent to the subject. In someembodiments, the system may optionally include circuitry configured topredict one or more locations in the pulmonary tract of the subjectwhere the at least one active agent was delivered in response to one ormore parameters associated with administration of the at least oneactive agent to the subject. In some embodiments, the system mayoptionally include circuitry configured to predict one or more locationsin the pulmonary tract of the subject where the at least one incentiveagent was delivered in response to one or more parameters associatedwith administration of the at least one incentive agent to the subject.In addition to the foregoing, other system aspects are described in theclaims, drawings, and text forming a part of the present disclosure.

In one aspect, a system includes, but is not limited to, means forassessing one or more parameters associated with use of an inhaler by asubject, means for administering at least one formulation to the subjectin response to assessing the one or more parameters associated with useof the inhaler, and means for administering at least one incentive agentto the subject in coordination with administering the at least oneactive agent. In some embodiments, the system may optionally includemeans for displaying a comparison of an assessed value associated withone or more respiration parameters with one or more levels associatedwith the one or more respiration parameters. In some embodiments, thesystem may optionally include means for instructing the subject toachieve one or more values associated with one or more respirationparameters. In some embodiments, the system may optionally include meansfor accepting information associated with one or more parametersassociated with the subject. In some embodiments, the system mayoptionally include means for assessing one or more parameters associatedwith administering the at least one active agent to the subject. In someembodiments, the system may optionally include means for assessing oneor more parameters associated with administering the at least oneincentive agent to the subject. In some embodiments, the system mayoptionally include means for predicting one or more locations in thepulmonary tract of the subject where the at least one active agent wasdelivered in response to one or more parameters associated withadministration of the at least one active agent to the subject. In someembodiments, the system may optionally include means for predicting oneor more locations in the pulmonary tract of the subject where the atleast one incentive agent was delivered in response to one or moreparameters associated with administration of the at least one incentiveagent to the subject. In addition to the foregoing, other system aspectsare described in the claims, drawings, and text forming a part of thepresent disclosure.

In one aspect, a system includes, but is not limited to, anon-transitory signal-bearing medium bearing one or more instructionsthat, when executed by one or more processing components, directperformance of operations that include at least: assessing one or moreparameters associated with use of an inhaler by a subject; administeringat least one active agent to the subject in response to assessing theone or more parameters associated with use of the inhaler; andadministering at least one incentive agent to the subject incoordination with administering the at least one active agent. In someembodiments, a system may optionally include one or more instructionsthat direct performance of an operation that includes at leastdisplaying a comparison of an assessed value associated with one or morerespiration parameters with one or more levels associated with the oneor more respiration parameters. In some embodiments, a system mayoptionally include one or more instructions that direct performance ofan operation that includes at least instructing the subject to achieveone or more values associated with one or more respiration parameters.In some embodiments, a system may optionally include one or moreinstructions that direct performance of an operation that includes atleast accepting information associated with one or more parametersassociated with the subject. In some embodiments, a system mayoptionally include one or more instructions that direct performance ofan operation that includes at least assessing one or more parametersassociated with administering the at least one active agent to thesubject. In some embodiments, a system may optionally include one ormore instructions that direct performance of an operation that includesat least assessing one or more parameters associated with administeringthe at least one incentive agent to the subject. In some embodiments, asystem may optionally include one or more instructions that directperformance of an operation that includes at least predicting one ormore locations in the pulmonary tract of the subject where the at leastone active agent was delivered in response to the one or more parametersassociated with administration of the at least one active agent to thesubject. In some embodiments, a system may optionally include one ormore instructions that direct performance of an operation that includesat least predicting one or more locations in the pulmonary tract of thesubject where the at least one incentive agent was delivered in responseto the one or more parameters associated with administration of the atleast one incentive agent to the subject. In some embodiments, a systemmay optionally include a non-transitory signal-bearing medium thatincludes at least a computer-readable medium. In some embodiments, asystem may optionally include a non-transitory signal-bearing mediumthat includes at least a recordable medium. In some embodiments, asystem may optionally include a non-transitory signal-bearing mediumthat includes at least a communications medium. In addition to theforegoing, other system aspects are described in the claims, drawings,and text forming a part of the present disclosure.

In one or more various aspects, means include but are not limited tocircuitry and/or programming for effecting the herein referencedfunctional aspects; the circuitry and/or programming can be virtuallyany combination of hardware, software, and/or firmware configured toeffect the herein referenced functional aspects depending upon thedesign choices of the system designer. In addition to the foregoing,other system aspects means are described in the claims, drawings, and/ortext forming a part of the present disclosure.

In one or more various aspects, related systems include but are notlimited to circuitry and/or programming for effecting theherein-referenced method aspects; the circuitry and/or programming canbe virtually any combination of hardware, software, and/or firmwareconfigured to effect the herein referenced method aspects depending uponthe design choices of the system designer. In addition to the foregoing,other system aspects are described in the claims, drawings, and/or textforming a part of the present application.

The foregoing is a summary and thus may contain simplifications,generalizations, inclusions, and/or omissions of detail; consequently,those skilled in the art will appreciate that the summary isillustrative only and is NOT intended to be in any way limiting. Otheraspects, features, and advantages of the devices and/or processes and/orother subject matter described herein will become apparent in theteachings set forth herein.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates an example system 100 in which embodiments may beimplemented.

FIG. 2 illustrates example components of system 100 in which embodimentsmay be implemented.

FIG. 3 illustrates example components of system 100 in which embodimentsmay be implemented.

FIG. 4 illustrates a cross-sectional partial side view of an exampleinhaler 400 in which embodiments may be implemented.

FIG. 4A illustrates a cross-sectional partial side view of an exampleinhaler 400 in which embodiments may be implemented.

FIG. 4B illustrates a cross-sectional partial side view of an exampleinhaler 400 in which embodiments may be implemented.

FIG. 5 illustrates a cross-sectional partial side view of an exampleinhaler 500 in which embodiments may be implemented.

FIG. 6 illustrates a cross-sectional partial side view of an exampleinhaler 600 in which embodiments may be implemented.

FIG. 6A illustrates a cross-sectional partial side view of an exampleinhaler 600 in which embodiments may be implemented.

FIG. 6B illustrates a cross-sectional partial side view of an exampleinhaler 600 in which embodiments may be implemented.

FIG. 7 illustrates a cross-sectional partial side view of an exampleinhaler 700 in which embodiments may be implemented.

FIG. 7A illustrates a cross-sectional partial side view of an exampleinhaler 700 in which embodiments may be implemented.

FIG. 7B illustrates a cross-sectional partial side view of an exampleinhaler 700 in which embodiments may be implemented.

FIG. 8 illustrates a cross-sectional partial side view of an exampleinhaler 800 in which embodiments may be implemented.

FIG. 8A illustrates a cross-sectional partial side view of an exampleinhaler 800 in which embodiments may be implemented.

FIG. 9 illustrates a cross-sectional partial side view of an exampleinhaler 900 in which embodiments may be implemented.

FIG. 9A illustrates a cross-sectional partial side view of an exampleinhaler 900 in which embodiments may be implemented.

FIG. 9B illustrates a cross-sectional partial side view of an exampleinhaler 900 in which embodiments may be implemented.

FIG. 10 illustrates an example operational flow 1000 in whichembodiments may be implemented.

FIG. 11 illustrates an example operational flow 1100 in whichembodiments may be implemented.

FIG. 12 illustrates an example operational flow 1200 in whichembodiments may be implemented.

FIG. 13 illustrates an example operational flow 1300 in whichembodiments may be implemented.

FIG. 14 illustrates an example operational flow 1400 in whichembodiments may be implemented.

FIG. 15 illustrates an example operational flow 1500 in whichembodiments may be implemented.

FIG. 16 illustrates an example operational flow 1600 in whichembodiments may be implemented.

FIG. 17 illustrates an example operational flow 1700 in whichembodiments may be implemented.

FIG. 18 illustrates an example operational flow 1800 in whichembodiments may be implemented.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the subject matterpresented here.

FIG. 1 illustrates an example system 100 in which numerous embodimentsmay be implemented. In some embodiments, system 100 may be implementedas an inhaler. In some embodiments, system 100 may include a housing 102having at least one flow channel 104 disposed therein. In someembodiments, system 100 may include at least one port 106 disposed inthe housing 102 and operably coupled to at least one flow channel 104and configured to provide fluid communication between at least tworeservoirs 122 and at least one flow channel 104. In some embodiments,system 100 may include one or more actuators 120. In some embodiments,system 100 may include one or more reservoirs 122. In some embodiments,system 100 may include one or more dose counters 118. In someembodiments, system 100 may include one or more performance indicators116. In some embodiments, system 100 may include one or more controlunits 108. In some embodiments, system 100 may include one or moresensors 114. In some embodiments, system 100 may include one or moreuser interfaces 110. In some embodiments, system 100 may include one ormore signals 112.

FIG. 2 illustrates example embodiments of components that may beincluded in system 100. The illustrated components include a sensor 114,a performance indicator 116, a user interface 110, and a housing 102.

FIG. 3 illustrates example embodiments of components that may beincluded in system 100. The illustrated components include a controlunit 108, a signal 112, a dose counter 118, an actuator 120, and areservoir 122.

Housing

With reference to FIGS. 1-3, in some embodiments, system 100 may includeone or more housings 102. A housing 102 may be configured in numerousways. In some embodiments, a housing may be configured for inclusionwithin an inhaler. In some embodiments, a housing 102 may include one ormore flow channels 104 disposed therein. In some embodiments, a housing102 may include a single flow channel 104 disposed therein. In someembodiments, a housing 102 may include a plurality of flow channels 104disposed therein. For example, in some embodiments, a housing 102 mayinclude a first flow channel 104 disposed therein that is configured todirect an active agent 214 to a subject using the inhaler, and a secondflow channel 104 disposed therein that is configured to direct anincentive agent 218 to the subject.

In some embodiments, a housing 102 may include one or more ports 106disposed therein. In some embodiments, a housing 102 may include atleast one port 106 disposed within the housing 102 and operably coupledto at least one flow channel 104 and configured to provide fluidcommunication between at least two reservoirs 122 and at least one flowchannel 104. Accordingly, in some embodiments, a port 106 may beconfigured to operably couple with one or more reservoirs 122 and directcontents released from the one or more reservoirs 122 into one or moreflow channels 104 disposed within a housing 102. In some embodiments, aport 106 may be configured to facilitate delivery of one or morepowdered active agents 214 from an active agent reservoir 212 into aflow channel 104. In some embodiments, a port 106 may be configured tofacilitate delivery of one or more powdered incentive agents 218 from anincentive agent reservoir 216 into a flow channel 104. In someembodiments, a port 106 may be aligned with an actuator 120 that isconfigured to propel a powdered formulation into a flow channel 106. Forexample, in some embodiments, a port 106 may be configured to allow apushrod actuator 256 to pass through the port 106 in order to propel apowdered formulation from a reservoir 122 into a flow channel 104. Insome embodiments, a port 106 may be configured to facilitate delivery ofone or more aerosolized formulations from a reservoir 122 into a flowchannel 104. For example, in some embodiments, a port 106 may beconfigured to operably couple with an aerosol canister that includes acanister body and a valve stem that extends from the canister body andinto a port 106 that is aligned with a flow channel 104. In someembodiments, a housing 102 may include at least one port 106 disposed inthe housing 102 and operably coupled to at least one flow channel 104and configured to receive one or more reservoirs 122. In someembodiments, a housing 102 may include two or more ports 106 disposedwithin the housing 102 that are each operably coupled to at least oneflow channel 104 and are each configured to receive a reservoir 122. Insome embodiments, a housing 102 may include one port 106 disposed in thehousing 102 that is operably coupled to at least one flow channel 104and configured to receive two or more reservoirs 122. A port 106 mayinclude numerous types of connectors that allow one or more reservoirs122 to be operably coupled to the port 106. Examples of such connectorsinclude, but are not limited to, friction fit connectors 186, screwconnectors 188, Leur-lock connectors 190, and the like. In someembodiments, a port 106 may include an actuator 120 that is operable tofacilitate at least partial release of contents from one or moreoperably coupled reservoirs 122. For example, in some embodiments, aport 106 may include a controllable valve 258 that may be opened andclosed to facilitate at least partial release of contents from anoperably coupled reservoir 122. In some embodiments, such a controllablevalve 258 may be operably coupled with a control unit 108 that isconfigured to control the operation of the controllable valve 258. Insome embodiments, such a controllable valve 258 may be operably coupledwith a sensor 114. In some embodiments, such a controllable valve 258may be operably coupled with a sensor 114 that is configured to controlthe operation of the controllable valve 258. In some embodiments, such acontrollable valve 258 may be operably coupled with a control unit 108and a sensor 114 that are configured to control operation of thecontrollable valve 258. Accordingly, a port 106 may be configured innumerous ways.

In some embodiments, a housing 102 may include at least one reservoirsupport 192. For example, in some embodiments, a housing 102 may includeat least one reservoir support 192 that is configured to support atleast one aerosol canister that includes a canister body and a valvestem that extends from the canister body with the valve stem beingreceivable by a port 106. In some embodiments, a housing 102 may includeat least one reservoir support 192 that is configured to support atleast one reservoir 122 that includes a conveyor with at least oneconveying drive configured to advance a blister strip that includes aplurality of blister packs that are filled with an active agent 214 oran incentive agent 218.

In some embodiments, a housing 102 may include at least one mouthpiece268 that is operably coupled with one or more flow channels 104. In someembodiments, a mouthpiece 268 may be operably coupled with one or moresensors 114. A mouthpiece 268 may be operably coupled with numeroustypes of sensors 114. Examples of such sensors 114 include, but are notlimited to, optical sensors 126, volume sensors 128, pressure sensors130, vacuum sensors 132, timers 134, phase Doppler interferometers 136,velocimeters 138, ultrasonic flow meters 140, and the like. In someembodiments, a mouthpiece 268 may include a sensor 14 that is configuredto assess the quality of physical contact between the mouth of a subjectand the mouthpiece 268. For example, in some embodiments, a pressuresensor (e.g., strain gauge, stress gauge, deformation sensor, and thelike) may be configured to assess the quality of physical contactbetween the mouth of a subject and the mouthpiece 268.

Reservoir

With continued reference to FIGS. 1-3, in some embodiments, system 100may include one or more reservoirs 122. A reservoir 122 may beconfigured in numerous ways. In some embodiments, a reservoir 122 mayinclude one or more reservoir receivers 220. In some embodiments, areservoir 122 may include one or more reservoir transmitters 222.Accordingly, in some embodiments, a reservoir 122 may transmit one ormore signals 112. In some embodiments, a reservoir 122 may receive oneor more signals 112.

In some embodiments, a reservoir 122 may be operably coupled with acontrol unit 108. In some embodiments, a reservoir 122 may be operablycoupled with a control unit 108 that controls operation of the reservoir122. For example, in some embodiments, a control unit 108 may direct anactive agent reservoir 212 that includes a conveyor with at least oneconveying drive to advance a blister strip that includes a plurality ofblister packs that are filled with a powdered active agent 214. In someembodiments, a reservoir 122 may be operably coupled with a sensor 114.In some embodiments, a reservoir 122 may be operably coupled with asensor 114 that controls operation of the reservoir 122. For example, insome embodiments, a sensor 114 may detect a quantity of an active agent214 released from an active agent reservoir 212 and then direct aconveying drive in an active agent reservoir 212 to advance a blisterstrip that includes a plurality of blister packs that are filled with apowdered active agent 214. In some embodiments, an active agentreservoir 122 may be operably coupled with a sensor 114 that detects aquantity of active agent 214 contained within the active agent reservoir212. In some embodiments, an incentive agent reservoir 216 may beoperably coupled with a sensor 114 that detects a quantity of anincentive agent 218 contained within the incentive agent reservoir 216.In some embodiments, an active agent reservoir 212 may be operablycoupled with a sensor 114 that detects a quantity of an active agent 214contained within the active agent reservoir 212 and a dose counter 118that displays the amount of active agent 214 contained within the activeagent reservoir 212. In some embodiments, an incentive agent reservoir216 may be operably coupled with a sensor 114 that detects a quantity ofan incentive agent 218 contained within the incentive agent reservoir216 and a dose counter 118 that displays the amount of the incentiveagent 218 contained within the incentive agent reservoir 216.

An active agent reservoir 212 may contain numerous types of activeagents 214. Examples of such active agents 214 include, but are notlimited to, steroids, anti-inflammatory drugs, bronchodilators,leukotriene modifiers, long-acting beta antagonists,1,3-dimethylxanthine, short-acting beta agonists,[8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]oct-3-yl]3-hydroxy-2-phenyl-propanoate,antibodies, and the like (see e.g., Remingtion: The Science and Practiceof Pharmacy, Lippincott, Williams & Wilkins, 20th edition, Baltimore,Md., USA (2000), Physicians' Desk Reference, Thomson PDR, 58th edition,Montvale, N.J. (2004); Merck Index, Merck and Co., 13th edition,Whitehouse Station, N.J. (2001); which are hereby incorporated byreference).

An incentive agent reservoir 216 may contain numerous types of incentiveagents 218. Examples of such incentive agents 218 include, but are notlimited to, flavoring agents, nicotine, ethanol, caffeine, and the like.

Active agents 214 and incentive agents 218 may be included in numeroustypes of formulations. In some embodiments, a formulation may be aliquid formulation. Accordingly, in some embodiments, a formulation mayinclude a carrier fluid. In some embodiments, a formulation may be anaerosolized formulation. In some embodiments, a formulation may be apowdered formulation. In some embodiments, a formulation may be apowdered inhalation formulation. Accordingly, in some embodiments, aformulation may include a carrier powder. In some embodiments, aformulation may include one active agent 214. In some embodiments, aformulation may include more than one active agent 214. Accordingly, insome embodiments, a formulation may include numerous combinations ofactive agents 214. In some embodiments, a formulation may include oneincentive agent 218. In some embodiments, a formulation may include morethan one incentive agent 218. Accordingly, in some embodiments, aformulation may include numerous combinations of incentive agents 218.

In some embodiments, a reservoir 122 may be configured to contain aliquid formulation. For example, in some embodiments, an active agentreservoir 212 may be configured as an aerosol canister that includes acanister body and a valve stem that extends from the canister body. Insome embodiments, contents may be at least partially released from anaerosol canister by depressing the valve stem relative to the canisterbody. In some embodiments, a reservoir 122 may be configured to containa powdered formulation. For example, in some embodiments, an activeagent reservoir 212 may include a conveyor with at least one conveyingdrive configured to advance a blister strip that includes a plurality ofblister packs that are filled with a powdered active agent 214. In someembodiments, an incentive agent reservoir 216 may contain an incentiveagent 218. In some embodiments, an incentive agent reservoir 216 may beconfigured to contain an incentive agent 218 that is in a liquidcarrier. In some embodiments, an incentive agent reservoir 216 may beconfigured to contain an incentive agent 218 that is in powdered form.

Actuator

With continued reference to FIGS. 1-3, in some embodiments, system 100may include one or more actuators 120. System 100 may include numeroustypes of actuators 120 and combinations of actuators 102. In someembodiments, an actuator 120 may be configured to facilitate at leastpartial release of contents from one or more reservoirs 122. Forexample, in some embodiments, an actuator 120 may be configured tofacilitate at least partial release of one or more active agents 214from one or more active agent reservoirs 212. In some embodiments, anactuator 120 may be configured to facilitate at least partial release ofone or more incentive agents 218 from one or more incentive agentreservoirs 216. Examples of actuators 120 include, but are not limitedto, controllable valves 258, pushrod actuators 258, regulators 260,pneumatic actuators 262, and the like. In some embodiments, an actuator120 may be configured as an aerosol canister content release mechanism270 that includes a pushrod actuator 256 that can depress an aerosolcanister to open a controllable valve 258 and release contents of theaerosol canister. In some embodiments, an actuator 256 may be configuredas a blister pack puncture mechanism 270 that includes a pushrodactuator 256 that can puncture a blister pack. In some embodiments, anactuator 120 may be configured as a blister pack puncture mechanism thatincludes a pushrod actuator 256 that can puncture a blister pack andpropel a powdered inhalation formulation 214 from the blister pack intothe at least one flow channel 104.

In some embodiments, an actuator 120 may include one or more actuatorreceivers 264. In some embodiments, an actuator 120 may include one ormore actuator transmitters 266. Accordingly, in some embodiments, anactuator 120 may transmit one or more signals 112. In some embodiments,an actuator 120 may receive one or more signals 112. In someembodiments, an actuator 120 may be operably coupled to one or moresensors 114. Accordingly, in some embodiments, an actuator 120 may becontrolled in response to one or more parameters that are detected byone or more sensors 114. For example, in some embodiments, a sensor 114may detect a quantity of an active agent 214 flowing through a flowchannel 104 and control the operation of one or more operably coupledactuators 120 in response to the amount of active agent 214 detected. Insome embodiments, a sensor 114 may detect a quantity of an incentiveagent 218 flowing through a flow channel 104 and control the operationof one or more operably coupled actuators 120 in response to the amountof incentive agent 218 detected. In some embodiments, a sensor 114 maydetect when a subject using an inhaler is inhaling and activate one ormore operably coupled actuators 120 to facilitate at least partialrelease from a reservoir 122 during the inhalation cycle. In someembodiments, a sensor 114 may detect when a subject using an inhaler isexhaling and deactivate one or more operably coupled actuators 120 tohalt release from a reservoir 122 during the exhalation cycle. In someembodiments, a sensor 114 may detect when a subject using an inhaler isholding their breath and deactivate one or more operably coupledactuators 120 to halt release from a reservoir 122 during the breathholding cycle.

Dose Counter

As further shown in FIGS. 1-3, in some embodiments, system 100 mayinclude one or more dose counters 118. Dose counters 118 may beconfigured in numerous ways. In some embodiments, a dose counter 118 mayinclude one or more dose counter receivers 250. In some embodiments, adose counter 118 may include one or more dose counter transmitters 252.Accordingly, in some embodiments, a dose counter 118 may transmit one ormore signals 112. In some embodiments, a dose counter 118 may receiveone or more signals 112.

In some embodiments, a dose counter 118 may be a mechanical dose counter244. For example, in some embodiments, a mechanical dose 244 counter mayinclude a ratchet mechanism that advances a numerical indicator everytime that an inhaler is activated to dispense either or both of anactive agent 214 and an incentive agent 218 (e.g., Wright et al.,Dispending apparatus, U.S. Pat. No. 8,689,785 and Kaar et al., Dosecounter for a metered-dose inhaler, U.S. Pat. No. 8,662,381; hereinincorporated by reference). In some embodiments, a dose counter 118 maybe an electronic dose counter 246 that includes an electronic displaythat displays the number of times that an inhaler is activated todispense either or both of an active agent 214 and an incentive agent218 (e.g., Solomon et al., Dose counter and recording method, U.S. Pat.No. 8,539,945; herein incorporated by reference). In some embodiments, adose counter 118 may be an audio dose counter 248 that includes an audiodisplay. In some embodiments, an audio display may be configured toindicate the number of times that an inhaler is activated to dispenseeither one or both of an active agent 214 and an incentive agent 218.For example, in some embodiments, an audio dose counter 248 may receiveinformation associated with the number of times that an inhaler has beenactivated to release either one or both of an active agent 214 and anincentive agent 218 and provide an audio display in the form of a humanvoice to report the information.

In some embodiments, a dose counter 118 may be operably coupled with andreceive information from one or more sensors 114. In some embodiments, adose counter 118 may be operably coupled with and receive informationfrom one or more control units 108. In some embodiments, a dose counter118 may receive information associated with the quantity of an activeagent 214 or an incentive agent 218 that is contained within an activeagent reservoir 212 or an incentive agent reservoir 216 and then displaythe information. In some embodiments, a dose counter 118 may receiveinformation associated with the quantity of an active agent 214 or anincentive agent 218 that is released through one or more flow channels104 and then display the information.

Performance Indicator

With continued reference to FIGS. 1-3, in some embodiments, system 100may include one or more performance indicators 116. Performanceindicators 116 may be configured in numerous ways. In some embodiments,a performance indicator 116 may include one or more indicator receivers156. In some embodiments, a performance indicator 116 may include one ormore indicator transmitters 158. Accordingly, in some embodiments, aperformance indicator 116 may transmit one or more signals 112. In someembodiments, a performance indicator 116 may receive one or more signals112. In some embodiments, a performance indicator 116 may include one ormore indicator processors 160. Accordingly, in some embodiments, aperformance indicator 116 may process information.

In some embodiments, a performance indicator 116 may include a display148. A performance indicator 116 may include numerous types of displays148. Examples of such displays 148 include, but are not limited to,visual displays 150, audio displays 152, tactile displays 154, and thelike. Examples of visual displays 150 include, but are not limited to,electronic visual displays 150 such as active displays and passivedisplays. In some embodiments, a visual display 150 may be containedwithin a mobile device such as a cellular telephone, a personal digitalassistant, a notepad computer, and the like. Accordingly, in someembodiments, a control unit 108 may be configured to transmitperformance information that is received by and displayed on a mobiledevice. In some embodiments, a sensor 114 may be configured to transmitperformance information that is received by and displayed on a mobiledevice. In some embodiments, performance information may be displayed ona head mounted display 148 such as an optical head-mounted display 148.In some embodiments, a performance indicator 116 may include a tactiledisplay 154 that is configured to vibrate. For example, in someembodiments, a performance indicator 116 may vibrate with an intensitythat is related to respiration performance, such as inhalationperformance, breath hold performance, and/or exhalation performance of asubject using an inhaler. In some embodiments, a performance indicator116 may include an audio display 152 that is configured to emit one ormore sounds. For example, in some embodiments, a performance indicator116 may have a tone that is related to respiration performance, such asinhalation performance, breath hold performance, and/or exhalationperformance of a subject using an inhaler. In some embodiments, aperformance indicator 116 may be configured to output a human voice thatindicates a level of respiration performance, such as inhalationperformance, breath hold performance, and/or exhalation performance of asubject using an inhaler. In some embodiments, a performance indicator116 may be configured to output a human voice that instructs a subjectto reach a level of respiration performance, such as inhalationperformance, breath hold performance, and/or exhalation performance of asubject using an inhaler. A performance indicator 116 may displayinformation that is related to numerous types of performance. Forexample, in some embodiments, a performance indicator 116 may indicateone or more flow levels of an active agent 214 through a flow channel104. In some embodiments, a performance indicator 116 may indicate oneor more levels of a vacuum that are applied to a flow channel 104 by asubject using the inhaler. In some embodiments, a performance indicator116 may indicate a volume of gas flowing through a flow channel 104during an inhalation cycle of a subject using an inhaler. In someembodiments, a performance indicator 116 may indicate a volume of gasflowing through a flow channel 104 during an exhalation cycle of asubject using an inhaler. In some embodiments, a performance indicator116 may indicate a period of time related to how long a subject using aninhaler holds their breath. In some embodiments, a performance indicator116 may indicate a velocity with which gas flows through a flow channel104. For example, in some embodiments, a performance indicator 116 mayindicate the velocity of gas flowing through a flow channel 104 duringan inhalation cycle by a subject using the inhaler. In some embodiments,a performance indicator 116 may indicate the velocity of gas flowingthrough a flow channel 104 during an exhalation cycle by a subject usingthe inhaler. Accordingly, a performance indicator 116 may be configuredto display information that is related to numerous parameters.

In some embodiments, a performance indicator 116 may be operably coupledwith one or more control units 108. In some embodiments, a performanceindicator 116 may be operably coupled with one or more sensors 114. Insome embodiments, a performance indicator 116 may be operably coupledwith one or more control units 108 and one or more sensors 114. In someembodiments, a performance indicator 116 may be configured to displayprocessed information that is received from a control unit 108. Forexample, in some embodiments, a performance indicator 116 may indicate aquantity of an active agent 214 that flows through a flow channel 104.In some embodiments, a performance indicator 116 may indicate a quantityof an active agent 214 to be released to reach a predetermined dosagelevel.

Sensor

As further shown in FIGS. 1-3, in some embodiments, system 100 mayinclude one or more sensors 114. System 100 may include numerous typesof sensors 114. Examples of sensors 114 include, but are not limited to,flow sensors 124 such as gas flow sensors 124 and liquid flow sensors124, volume sensors 128, optical sensors 126, pressure sensors 130,vacuum sensors 132, timers 134, phase Doppler interferometers 136,velocimeters 138, ultrasonic flow meters 140, and the like.

In some embodiments, a sensor 114 may include one or more sensorreceivers 144. In some embodiments, a sensor 114 may include one or moresensor transmitters 142. In some embodiments, a sensor 114 may receiveone or more signals 112. In some embodiments, a sensor 114 may transmitone or more signals 112. In some embodiments, a sensor 114 may includeone or more sensor processors 146. Accordingly, in some embodiments, asensor 114 may process information.

In some embodiments, one or more sensors 114 may be operably coupledwith one or more flow channels 104 that are disposed within a housing102. In some embodiments, a sensor 114 may be configured to measure thevelocity with which gas flows through a flow channel 104. In someembodiments, a sensor 114 may be configured to measure the velocity withwhich liquid flows through a flow channel 104. In some embodiments, avolume sensor 128 may be used to measure a volume of gas flowing througha flow channel 104. In some embodiments, a volume sensor 128 may be usedto measure a volume of liquid flowing through a flow channel 104. Insome embodiments, a sensor 114 may be configured to measure a quantityof an active agent 214 that flows through a flow channel 104. In someembodiments, a vacuum sensor 132 may be used to measure an amount ofvacuum pressure applied to a flow channel 104. In some embodiments, apressure sensor 130 may be used to measure an amount of gas pressureapplied to a flow channel 104. In some embodiments, a timer 134 may beconfigured to measure an amount of time related to a respirationparameter. For example, in some embodiments, a timer 134 may be used todetermine a time period during one or more of an inhalation cycle, anexhalation cycle, or a breath hold cycle occurring during use of aninhaler. In some embodiments, a pressure sensor 130 may be operablycoupled to a mouthpiece 268 of an inhaler and configured to assess thequality of physical contact between the mouth of a subject and themouthpiece. Accordingly, in some embodiments, such a pressure sensor 130may be configured to measure stress and/or strain on the mouthpiece 268.

In some embodiments, a sensor 114 may be operably coupled with one ormore control units 108. Accordingly, in some embodiments, a control unit108 may be configured to control the operation of one or more operablycoupled sensors 114. In some embodiments, a sensor 114 may be operablycoupled with one or more actuators 120 that are configured to facilitateat least partial release of contents from one or more reservoirs 122.For example, in some embodiments, a sensor 114 may be operably coupledto an actuator 120 and configured to facilitate at least partial releaseof one or more active agents 214 from an active agent reservoir 212 in amanner that is dependent on the quantity of an active agent 214 detectedflowing through a flow channel 104. In some embodiments, a sensor 114may be coupled to a control unit 108 and to an actuator 120.Accordingly, in some embodiments, a control unit 108 may receivedetected information from one or more sensors 114 and then control oneor more actuators 120 in response to the information.

User Interface

With continued reference to FIGS. 1-3, in some embodiments, system 100may include one or more user interfaces 110. System 100 may includenumerous types of user interfaces 110. Examples of user interfaces 110include, but are not limited to, graphical interfaces 162, monitors 166,touchscreens 172, touchpads 170, keyboards 168, mobile device interfaces164, and the like. In some embodiments, a user interface may include oneor more user transmitters 176. In some embodiments, a user interface mayinclude one or more user receivers 178. In some embodiments, a userinterface may include one or more interface processors 182. Accordingly,in some embodiments, a user interface 110 may transmit one or moresignals 112, receive one or more signals 112, and process one or moresignals 112.

In some embodiments, a user interface 110 may transmit one or moresignals 112 that are received by one or more control units 108. In someembodiments, a user interface 110 may transmit one or more signals 112that are received by one or more sensors 114. In some embodiments, auser interface 110 may transmit one or more signals 112 that arereceived by one or more performance indicators 116. In some embodiments,a user interface 110 may transmit one or more signals 112 that arereceived by one or more dose counters 118. In some embodiments, a userinterface 110 may transmit one or more signals 112 that are received byone or more actuators 120.

In some embodiments, a user interface 110 may receive one or moresignals 112 that are transmitted by one or more control units 108. Insome embodiments, a user interface 110 may receive one or more signals112 that are transmitted by one or more sensors 114. In someembodiments, a user interface 110 may receive one or more signals 112that are transmitted by one or more performance indicators 116. In someembodiments, a user interface 110 may receive one or more signals 112that are transmitted by one or more dose counters 118.

In some embodiments, a subject may enter information into a userinterface 110 that transmits one or more signals 112 that include theinformation that are received by one or more control units 108. Examplesof such information include, but are not limited to, information relatedto a subject's height, weight, age, allergies, respiration parameters,physical fitness level, information related to one or more maladiesassociated with the subject, information related to drugs used by thesubject, and the like.

Signal

Numerous types of signals 112 may be used within system 100. Examples ofsuch signals 112 include, but are not limited to, wireless signals 224,optical signals 226, magnetic signals 228, radiofrequency signals 232,hardwired signals 234, infrared signals 236, audible signals 238, analogsignals 242, digital signals 240, Bluetooth signals 230, and the like.Accordingly, system 100 may include receivers, transmitters, andprocessors that are configured to receive, transmit, and processnumerous types of signals 112. A signal 112 may include numerous typesof information. For example, in some embodiments, a signal 112 mayinclude information associated with one or more respiration parameters.In some embodiments, a signal 112 may include information associatedwith release of one or more active agents 214 from an active agentreservoir 212. In some embodiments, a signal 112 may include informationassociated with release of one or more incentive agents 218 from anincentive agent reservoir 216.

Control Unit

As further depicted in FIGS. 1-3, in some embodiments, system 100 mayinclude one or more control units 108. In some embodiments, a controlunit 108 may include one or more control computers 206. In someembodiments, a control unit 108 may include one or more controlreceivers 194. In some embodiments, a control unit 108 may include oneor more control transmitters 196. In some embodiments, a control unit108 may include one or more control processors 198. In some embodiments,a control unit 108 may include control memory 204. In some embodiments,a control unit 108 may include control logic 200. In some embodiments, acontrol unit 108 may include performance logic 202. In some embodiments,a control unit 108 may include one or more power supplies 208. In someembodiments, a control unit 108 may include one or more controlinterfaces 210.

In some embodiments, a control unit 108 may receive one or more signals112 that are transmitted by one or more user interfaces 110. In someembodiments, a control unit 108 may receive one or more signals 112 thatare transmitted by one or more sensors 114. In some embodiments, acontrol unit 108 may receive one or more signals 112 that aretransmitted by one or more performance indicators 116. In someembodiments, a control unit 108 may receive one or more signals 112 thatare transmitted by one or more dose counters 118. In some embodiments, acontrol unit 108 may receive one or more signals 112 that aretransmitted by one or more actuators 120.

In some embodiments, a control unit 108 may transmit one or more signals112 that are received by one or more user interfaces 110. In someembodiments, a control unit 108 may transmit one or more signals 112that are received by one or more sensors 114. In some embodiments, acontrol unit 108 may transmit one or more signals 112 that are receivedby one or more actuators 120. In some embodiments, a control unit 108may transmit one or more signals 112 that are received by one or moreperformance indicators 116. In some embodiments, a control unit 108 maytransmit one or more signals 112 that are received by one or more dosecounters 118.

In some embodiments, a control unit 108 may transmit one or more signals112 that direct the operation of one or more actuators 120. For example,in some embodiments, a control unit 108 may transmit one or more signals112 that direct an actuator 120 to at least partially release contentsfrom one or more reservoirs 122. In some embodiments, a control unit 108may transmit one or more signals 112 that direct an actuator 120 not torelease contents from one or more reservoirs 122. For example, in someembodiments, a control unit 108 may receive information from one or moresensors 114 that is related to inhalation and exhalation through a flowchannel 104 by a subject using an inhaler. The control unit 108 may thendirect one or more actuators 120 to at least partially release contentsfrom one or more reservoirs 122 during an inhalation cycle through aninhaler and then direct the one or more actuators 120 to not releasecontents from the one or more reservoirs 122 during an exhalation cyclethrough an inhaler. In some embodiments, a control unit 108 may directthe operation of more than one actuator 120. For example, in someembodiments, a control unit 108 may direct a first actuator 120 to atleast partially release an active agent 214 from an active agentreservoir 212 and then direct a second actuator 120 to at leastpartially release an incentive agent 218 from an incentive agentreservoir 216. In some embodiments, a control unit 108 may direct afirst actuator 120 to at least partially release an incentive agent 218from an incentive agent reservoir 216 and then direct a second actuator120 to at least partially release an active agent 214 from an activeagent reservoir 212. In some embodiments, a control unit 108 may directa first actuator 120 to at least partially release an incentive agent218 from an incentive agent reservoir 216 and direct a second actuator120 to at least partially release an active agent 214 from an activeagent reservoir 212 at substantially the same time.

In some embodiments, a control unit 108 may transmit one or more signals112 that are received by one or more performance indicators 116. Forexample, in some embodiments, a control unit 108 may receive one or moresignals 112 from a sensor 114 that include information related torespiration performance by a subject using an inhaler. The control unit108 may then transmit one or more signals 112 that are received by aperformance indicator 116 that direct the performance indicator 116 toindicate the level of assessed respiration performance. In someembodiments, a control unit 108 may receive one or more signals 112 fromone or more sensors 114 that include information related to a quantityof an active agent 214 that flowed through a flow channel 104. In someembodiments, the control unit 108 may then transmit one or more signals112 that are received by one or more performance indicators 116 thatdirect the one or more performance indicators 116 to indicate thequantity of the active agent 214 that flowed through a flow channel 104.In some embodiments, a control unit 108 may transmit one or more signals112 that are received by one or more performance indicators 116 thatdirect the one or more performance indicators 116 to indicate a quantityof an active agent 214 that needs to be release from an active agentreservoir 212 to reach a predetermined dosage.

In some embodiments, a control unit 108 may receive one or more signals112 that are transmitted by one or more dose counters 118. For example,in some embodiments, a control unit 108 may receive one or more signals112 that include information related to the number of doses of an activeagent 214 or an incentive agent 218 that have been released from anactive agent reservoir 212 or an incentive agent reservoir 216. In someembodiments, a control unit 108 may receive one or more signals 112 thatwere transmitted by a dose counter 118 that include information relatedto the number of doses of an active agent 214 that are contained in anactive agent reservoir 212. In some embodiments, a control unit 108 mayreceive one or more signals 112 that were transmitted by a dose counter118 that include information related to the number of doses of anincentive agent 218 that are contained in an incentive agent reservoir216.

In some embodiments, a control unit 108 may compare one or moreparameters to one or more threshold levels that are associated with theone or more parameters. For example, in some embodiments, a control unit108 may receive one or more assessed values from one or more sensors 114that are associated with a volume of flow through one or more flowchannels 104 disposed within an inhaler. The control unit 108 maycompare the one or more assessed values to one or more threshold valuesthat are associated with a volume of flow through a flow channel 104 todetermine if the one or more assessed values meet or exceed the one ormore threshold values. In some embodiments, a control unit 108 maycompare one or more assessed values that are related to one or moreparameters to one or more ranges of levels associated with the one ormore parameters. In some embodiments, a control unit 108 may compare oneor more assessed values that are related to one or more parameters toone or more ranges of levels associated with the one or more parametersto determine in the one or more assessed values are within the one ormore ranges of levels associated with the one or more parameters. Forexample, in some embodiments, a control unit 108 may receive one or moresignals 112 transmitted by one or more sensors 114 that include one ormore assessed values associated with a volume of flow through one ormore flow channels 104 disposed within an inhaler. The control unit 108may compare the one or more assessed values to one or more ranges ofvalues that are associated with a volume of flow through a flow channelto determine if the one or more assessed values are within the one ormore ranges of values. Exemplary ranges of flow through one or more flowchannels 104 disposed within an inhaler include, but are not limited to,about 5 liters per minute and about 200 liters per minute, about 30liters per minute and about 150 liters per minute, about 50 liters perminute and about 100 liters per minute, about 20 liters per minute andabout 60 liters per minute, about 30 liters per minute and about 50liters per minute, about 50 liters per minute and about 200 liters perminute, about 75 liters per minute and about 200 liters per minute,about 100 liters per minute and about 200 liters, about 125 liters perminute and about 200 liters per minute, about 150 liters per minute andabout 200 liters per minute, about 175 liters per minute and about 200liters per minute, about 50 liters per minute and about 150 liters perminute, about 60 liters per minute and about 150 liters per minute, andabout 60 liters per minute and about 120 liters per minute.

Numerous threshold values may be assigned to a parameter. In someembodiments, a threshold value may be determined based in the age of asubject using an inhaler. For example, in some embodiments, a thresholdvalue associated with the velocity of flow through a flow channel 104during an inhalation cycle of a child using an inhaler may be selectedto provide for adequate delivery of an active agent 214 to the child. Insome embodiments, a threshold value associated with the velocity of flowthrough a flow channel 104 during an inhalation cycle of an adult usingan inhaler may be selected to provide for adequate delivery of aformulation 214 to the adult. Accordingly, threshold values may beselected with regard to numerous parameters. Examples of such parametersinclude, but are not limited to, age of a subject, identity of an activeagent 214 that is to be delivered, location within the pulmonary tractwhere an active agent 214 is to be delivered, quantity of an activeagent 214 that is to be delivered, and the like. Accordingly, a controlunit may compare numerous types of parameters to threshold levels thatare associated with the one or more parameters. In some embodiments, athreshold value may be selected by a health care provider.

FIG. 4 illustrates a partial cross-sectional side view of system 400that is configured as an embodiment of an inhaler. System 400 includes ahousing 102 having a flow channel 104 disposed therein. Also illustratedare two ports 106 disposed in the housing 102 in fluid communicationwith the flow channel 104. An active agent reservoir 212 is illustratedas being operably coupled to one of the ports 106. An incentive agentreservoir 216 is illustrated as being operably coupled to the other port106. The active agent reservoir 212 and the incentive agent reservoir216 are illustrated as being held within a reservoir support 192. Theactive agent reservoir 212 and the incentive agent reservoir 216 areboth configured as aerosol canisters that include a canister body and avalve stem that extends from the canister body into each of the ports106. The active agent reservoir 212 includes a controllable valve 258.The incentive agent reservoir 216 also includes a controllable valve258. Both of the controllable valves 258 are illustrated as being closedas indicated by a closed circle. Flow through the flow channel 104 isillustrated by the two arrows indicating directional flow through theflow channel 104. Flow from right to left toward the mouthpiece 268 isrelated to an inhalation cycle of a subject using the inhaler. Flow fromleft to right away from the mouthpiece 268 is related to an exhalationcycle of a subject using the inhaler. A flow sensor 124 is operablycoupled to the flow channel 104 and configured to detect flow throughthe flow channel 104. An aerosol canister content release mechanism 270is illustrated with a pushrod actuator 256 operably coupled with each ofthe active agent reservoir 212 and the incentive agent reservoir 216.The aerosol canister content release mechanism 270 is operably coupledwith a control unit 108. The control unit 108 is configured to directoperation of the aerosol canister content release mechanism 270 tocontrol each of the pushrod actuators 256 to facilitate at least partialrelease from each of the active agent reservoir 212 and the incentiveagent reservoir 216. The control unit 108 is operably coupled with theflow sensor 124. Accordingly, in some embodiments, the control unit 108may be configured to facilitate at least partial release from one orboth of the active agent reservoir 212 and the incentive agent reservoir216. In some embodiments, the control unit 108 may be configured tofacilitate at least partial release from one or both of the active agentreservoir 212 and the incentive agent reservoir 216 during an inhalationcycle. In some embodiments, the control unit 108 may be configured tohalt at least partial release from one or both of the active agentreservoir 212 and the incentive agent reservoir 216 during an exhalationcycle. In some embodiments, the control unit 108 may be configured tofacilitate at least partial release from an active agent reservoir 212and then facilitate at least partial release from an incentive agentreservoir 216. In some embodiments, the control unit 108 may beconfigured to facilitate at least partial release from an incentiveagent reservoir 216 and then facilitate at least partial release from anactive agent reservoir 212. In some embodiments, the control unit 108may be configured to facilitate at least partial release from both theincentive agent reservoir 216 and from the active agent reservoir 212 atsubstantially the same time. In some embodiments, the flow sensor 124may be configured to detect a quantity of an active agent 214 that isincluded in the exhalant of a subject using the inhaler. Accordingly, insome embodiments, such information may be transmitted to the controlunit 108 that may use the information to calculate a quantity of theactive agent 214 that needs to be administered to the subject to reach apredetermined dosage. The control unit 108 may then control operation ofthe aerosol canister content release mechanism 270 to administer anadditional quantity of the active agent 214 to reach the predetermineddosage.

FIG. 4A illustrates a partial cross-sectional side view of system 400that is configured as an embodiment of an inhaler that is illustrated asbeing activated to at least partially release an active agent 214 froman active agent reservoir 212. System 400 is shown as an embodiment ofan inhaler that includes a housing 102 having a flow channel 104disposed therein. Also illustrated are two ports 106 disposed in thehousing 102 in fluid communication with the flow channel 104. An activeagent reservoir 212 is illustrated as being operably coupled to one ofthe ports 106. An incentive agent reservoir 216 is illustrated as beingoperably coupled to the other port 106. The active agent reservoir 212and the incentive agent reservoir 216 are illustrated as being heldwithin a reservoir support 192. The active agent reservoir 212 and theincentive agent reservoir 216 are both configured as aerosol canistersthat include a canister body and a valve stem that extends from thecanister body into each of the ports 106. The active agent reservoir 212includes a controllable valve 258. The incentive agent reservoir 216also includes a controllable valve 258. The controllable valve 258 thatis operably coupled to the active agent reservoir 212 is illustrated asbeing open as indicated by an open circle. The controllable valve 258that is operably coupled to the incentive agent reservoir 216 isillustrated as being closed as indicated by a closed circle. Flowthrough the flow channel 104 is illustrated by an arrow indicating rightto left flow toward the mouthpiece 268 through the flow channel 104.Flow from right to left toward the mouthpiece 268 is related to aninhalation cycle of a subject using the inhaler. A flow sensor 124 isoperably coupled to the flow channel 104 and configured to detect flowthrough the flow channel 104. An aerosol canister content releasemechanism 270 is illustrated with a pushrod actuator 256 operablycoupled with each of the active agent reservoir 212 and the incentiveagent reservoir 216. The aerosol canister content release mechanism 270is operably coupled with a control unit 108. The control unit 108 isconfigured to direct operation of the aerosol canister content releasemechanism 270 to control each of the pushrod actuators 256 to facilitateat least partial release from each of the active agent reservoir 212 andthe incentive agent reservoir 216. The control unit 108 is operablycoupled with the flow sensor 124. The pushrod actuator 256 that isoperably associated with the active agent reservoir 212 is illustratedas being in an activated state. In the activated state, the pushrodactuator 256 compresses the canister body of the active agent reservoir212 that is configured as an aerosol canister toward the valve stem thatextends from the canister body to facilitate at least partial release ofactive agent 214 from the active agent reservoir 212 through the port106 and into the flow channel 104.

FIG. 4B illustrates a partial cross-sectional side view of system 400that is configured as an embodiment of an inhaler that is illustrated asbeing activated to at least partially release incentive agent 218 froman incentive agent reservoir 216. System 400 is illustrated as includinga housing 102 having a flow channel 104 disposed therein. Alsoillustrated are two ports 106 disposed in the housing 102 in fluidcommunication with the flow channel 104. An active agent reservoir 212is illustrated as being operably coupled to one of the ports 106. Anincentive agent reservoir 216 is illustrated as being operably coupledto the other port 106. The active agent reservoir 212 and the incentiveagent reservoir 216 are illustrated as being held within a reservoirsupport 192. The active agent reservoir 212 and the incentive agentreservoir 216 are both configured as aerosol canisters that include acanister body and a valve stem that extends from the canister body intoeach of the ports 106. The active agent reservoir 212 includes acontrollable valve 258. The incentive agent reservoir 216 also includesa controllable valve 258. The controllable valve 258 that is operablycoupled to the incentive agent reservoir 216 is illustrated as beingopen as indicated by an open circle. The controllable valve 258 that isoperably coupled to the active agent reservoir 212 is illustrated asbeing closed as indicated by a closed circle. Flow through the flowchannel 104 is illustrated by an arrow indicating right to left flowtoward the mouthpiece 268 through the flow channel 104. Flow from rightto left toward the mouthpiece 268 is related to an inhalation cycle of asubject using the inhaler. A flow sensor 124 is operably coupled to theflow channel 104 and configured to detect flow through the flow channel104. An aerosol canister content release mechanism 270 is illustratedwith a pushrod actuator 256 operably coupled with each of the activeagent reservoir 212 and the incentive agent reservoir 216. The aerosolcanister content release mechanism 270 is operably coupled with acontrol unit 108. The control unit 108 is configured to direct operationof the aerosol canister content release mechanism 270 to control each ofthe pushrod actuators 256 to facilitate at least partial release fromeach of the active agent reservoir 212 and the incentive agent reservoir216. The control unit 108 is operably coupled with the flow sensor 124.The pushrod actuator 256 that is operably associated with the incentiveagent reservoir 216 is illustrated as being in an activated state. Inthe activated state, the pushrod actuator 256 compresses the canisterbody of the incentive agent reservoir 216 that is configured as anaerosol canister toward the valve stem that extends from the canisterbody to facilitate at least partial release of incentive agent 218 fromthe incentive agent reservoir 216 through the port 106 and into the flowchannel 104.

FIG. 5 illustrates a partial cross-sectional side view of system 500that is configured as an embodiment of an inhaler that is illustrated asbeing activated to at least partially release active agent 214 from anactive agent reservoir 212. System 500 is shown as an embodiment of aninhaler that includes a housing 102 having a flow channel 104 disposedtherein. Also illustrated are two ports 106 disposed in the housing 102in fluid communication with the flow channel 104. An active agentreservoir 212 is illustrated as being operably coupled to one of theports 106. An incentive agent reservoir 216 is illustrated as beingoperably coupled to the other port 106. The active agent reservoir 212and the incentive agent reservoir 216 are illustrated as being heldwithin a reservoir support 192. The active agent reservoir 212 and theincentive agent reservoir 216 are both configured as aerosol canistersthat include a canister body and a valve stem that extends from thecanister body into each of the ports 106. The active agent reservoir 212includes a controllable valve 258. The incentive agent reservoir 216also includes a controllable valve 258. The controllable valve 258 thatis operably coupled to the active agent reservoir 212 is illustrated asbeing open as indicated by an open circle. The controllable valve 258that is operably coupled to the incentive agent reservoir 216 isillustrated as being closed as indicated by a closed circle. Flowthrough the flow channel 104 is illustrated by an arrow indicating rightto left flow toward the mouthpiece 268 through the flow channel 104.Flow from right to left toward the mouthpiece 268 is related to aninhalation cycle of a subject using the inhaler. A flow sensor 124 isoperably coupled to the flow channel 104 and configured to detect flowthrough the flow channel 104. An aerosol canister content releasemechanism 270 is illustrated with a pushrod actuator 256 operablycoupled with each of the active agent reservoir 212 and the incentiveagent reservoir 216. The aerosol canister content release mechanism 270is operably coupled with a control unit 108. The control unit 108 isconfigured to direct operation of the aerosol canister content releasemechanism 270 to control each of the pushrod actuators 256 to facilitateat least partial release from each of the active agent reservoir 212 andthe incentive agent reservoir 216. The control unit 108 is operablycoupled with the flow sensor 124. The pushrod actuator 256 that isoperably associated with the formulation reservoir 212 is illustrated asbeing in an activated state. In the activated state, the pushrodactuator 256 compresses the canister body of the formulation reservoir212 that is configured as an aerosol canister toward the valve stem thatextends from the canister body to facilitate at least partial release offormulation 214 from the formulation reservoir 212 through the port 106and into the flow channel 104. A dose counter 118 is illustrated. Insome embodiments, a dose counter 118 may be operably coupled with acontrol unit 108. In some embodiments, a dose counter 118 may beoperably coupled with a flow sensor 124. The dose counter 118 in thisexample may be configured to indicate the number of doses administeredfrom the active agent reservoir 212.

FIG. 6 illustrates a partial cross-sectional side view of system 600.System 600 is shown as an embodiment of an inhaler that includes ahousing 102 having a flow channel 104 disposed therein. Also illustratedare two ports 106 disposed in the housing 102 and in fluid communicationwith the flow channel 104. An active agent reservoir 212 is illustratedas being operably coupled to one of the ports 106. An incentive agentreservoir 216 is illustrated as being operably coupled to the other port106. The active agent reservoir 212 and the incentive agent reservoir216 are illustrated as being held within a reservoir support 192. Theactive agent reservoir 212 and the incentive agent reservoir 216 areboth configured as aerosol canisters that include a canister body and avalve stem that extends from the canister body into each of the ports106. The active agent reservoir 212 includes a controllable valve 258.The incentive agent reservoir 216 also includes a controllable valve258. Both of the controllable valves 258 are illustrated as being closedas indicated by the closed circles. Flow through the flow channel 104 isillustrated by the two arrows indicating directional flow through theflow channel 104. Flow from right to left toward the mouthpiece 268 isrelated to an inhalation cycle of a subject using the inhaler. Flow fromleft to right away from the mouthpiece 268 is related to an exhalationcycle of a subject using the inhaler.

A flow sensor 124 is operably coupled to the flow channel 104 andconfigured to detect flow through the flow channel 104. An aerosolcanister content release mechanism 270 is illustrated with a pushrodactuator 256 operably coupled with each of the active agent reservoir212 and the incentive agent reservoir 216. The aerosol canister contentrelease mechanism 270 is operably coupled with a control unit 108. Thecontrol unit 108 is configured to direct operation of the aerosolcanister content release mechanism 270 to control each of the pushrodactuators 256 to facilitate at least partial release from each of theactive agent reservoir 212 and the incentive agent reservoir 216.Accordingly, in some embodiments, the control unit 108 may be configuredto facilitate at least partial release from one or both of the activeagent reservoir 212 and the incentive agent reservoir 216. The controlunit 108 is operably coupled with the flow sensor 124. In someembodiments, the control unit 108 may be configured to facilitate atleast partial release from one or both of the active agent reservoir 212and the incentive agent reservoir 216 during an inhalation cycle. Insome embodiments, the control unit 108 may be configured to halt atleast partial release from one or both of the active agent reservoir 212and the incentive agent reservoir 216 during an exhalation cycle. Insome embodiments, the control unit 108 may be configured to facilitateat least partial release from the active agent reservoir 212 and thenfacilitate at least partial release from the incentive agent reservoir216. In some embodiments, the control unit 108 may be configured tofacilitate at least partial release from the incentive agent reservoir216 and then facilitate at least partial release from the active agentreservoir 212. In some embodiments, the control unit 108 may beconfigured to facilitate at least partial release from the incentiveagent reservoir 216 and the active agent reservoir 212 at substantiallythe same time. In some embodiments, the flow sensor 124 may beconfigured to detect a quantity of an active agent 214 that is includedin the exhalant of a subject using the inhaler. Accordingly, in someembodiments, such information may be transmitted to the control unit 108that may use the information to calculate a quantity of the active agent214 that needs to be administered to a subject using the inhaler toreach a predetermined dosage. The control unit 108 may then control theoperation of the aerosol canister content release mechanism 270 toadminister an additional amount of the active agent 214 to reach thepredetermined dosage.

As further shown in FIG. 6, system 600 is illustrated as including aperformance indicator 116. In some embodiments, performance indicator116 may be operably coupled to a flow sensor 124. Accordingly, in someembodiments, a performance indicator 116 may be configured to indicateone or more values related to one or more respiration parametersassociated with use of the inhaler by a subject. Examples of suchrespiration parameters may include, but are not limited to, thoserelated to inhalation performance, exhalation performance, breath holdperformance, and the like. The performance indicator 116 in FIG. 6 isillustrated as indicating a low level of respiration performance ascompared to the greater level of respiration performance indicated inFIG. 6A. In some embodiments, the flow sensor 124 may be operablycoupled with an aerosol canister content release mechanism 270 that isconfigured to activate a pushrod actuator 256 to facilitate at leastpartial release of contents from one or both of the active agentreservoir 212 and the incentive agent reservoir 216 when one or moremeasured respiration parameters meet or exceed one or more thresholdvalues associated with the one or more respiration parameters. Anoptical sensor 126 is illustrated as being operably coupled with theflow channel 104. In some embodiments, an optical sensor 126 may beconfigured to assess a quantity of either both of an active agent 214and an incentive agent 218 that flows through the flow channel 104.Accordingly, in some embodiments, an optical sensor 126 may be operablycoupled with a control unit 108 that is configured to assess a quantityof an active agent 214 that is delivered to a subject using the inhalerand then determine an additional amount of active agent 214 that shouldbe delivered to the subject to reach a predetermined dosage level. Thecontrol unit 108 may then control the operation of an aerosol canistercontent release mechanism 270 to facilitate at least partial releasefrom an active agent reservoir 212 to deliver a quantity of an activeagent 214 to the subject to reach the predetermined dosage level.

FIG. 6A illustrates a partial cross-sectional side view of system 600.System 600 is shown as an embodiment of an inhaler that is activated toat least partially release an active agent 214 from an active agentreservoir 212. System 600 includes a housing 102 having a flow channel104 disposed therein. Also illustrated are two ports 106 disposed in thehousing 102 and in fluid communication with the flow channel 104. Anactive agent reservoir 212 is illustrated as being operably coupled toone of the ports 106. An incentive agent reservoir 216 is illustrated asbeing operably coupled to the other port 106. The active agent reservoir212 and the incentive agent reservoir 216 are illustrated as being heldwithin a reservoir support 192. The active agent reservoir 212 and theincentive agent reservoir 216 are both configured as aerosol canistersthat include a canister body and a valve stem that extends from thecanister body into each of the ports 106. The active agent reservoir 212includes a controllable valve 258. The incentive agent reservoir 216also includes a controllable valve 258. The controllable valve 258 thatis operably coupled to the active agent reservoir 212 is illustrated asbeing open as indicated by an open circle. The controllable valve 258that is operably coupled to the incentive agent reservoir 216 isillustrated as being closed as indicated by a closed circle. Flowthrough the flow channel 104 is illustrated by one arrow indicatingdirectional flow through the flow channel 104 from right to left towardthe mouthpiece 268 and indicates an inhalation cycle of a subject usingthe inhaler. A flow sensor 124 is operably coupled to the flow channel104 and configured to detect flow through the flow channel 104. Anaerosol canister content release mechanism 270 is illustrated with apushrod actuator 256 operably coupled with each of the active agentreservoir 212 and the incentive agent reservoir 216. The aerosolcanister content release mechanism 270 is operably coupled with acontrol unit 108. The control unit 108 is configured to direct operationof the aerosol canister content release mechanism 270 to control each ofthe pushrod actuators 256 to facilitate at least partial release fromeach of the active agent reservoir 212 and the incentive agent reservoir216. Accordingly, in some embodiments, the control unit 108 may beconfigured to facilitate at least partial release from one or both ofthe active agent reservoir 212 and the incentive agent reservoir 216.The control unit 108 is operably coupled with the flow sensor 124. Insome embodiments, the control unit 108 may be configured to facilitateat least partial release from one or both of the active agent reservoir212 and the incentive agent reservoir 216 during an inhalation cycle. Insome embodiments, the control unit 108 may be configured to halt atleast partial release from one or both of the active agent reservoir 212and the incentive agent reservoir 216 during an exhalation cycle.

As noted above, in some embodiments, an inhaler may include an operablycoupled performance indicator 116. The performance indicator 116 in FIG.6A is illustrated as indicating a high level of respiration performanceas compared to the respiration performance indicated in FIG. 6. In someembodiments a control unit 108 may be configured to control theoperation of an aerosol canister content release mechanism 270 that isconfigured to activate a pushrod actuator 256 to facilitate at leastpartial release of contents from one or both of the active agentreservoir 212 and the incentive agent reservoir 216 when one or moremeasured respiration parameters meet or exceed one or more thresholdvalues associated with the one or more respiration parameters.Accordingly, in FIG. 6A the pushrod actuator 256 that is operablycoupled to the active agent reservoir 212 is shown as being activated toat least partially release active agent 214 from the active agentreservoir 212 in response to the high level of respiration performance.An optical sensor 126 is illustrated as being operably coupled with theflow channel 104. In some embodiments, an optical sensor 126 may beconfigured to determine a quantity of either or both of an active agent214 and an incentive agent 118 that flows through the flow channel 104.Accordingly, in some embodiments, an optical sensor 126 may be operablycoupled with a control unit 108 that is configured to determine aquantity of an active agent 214 that is delivered to a subject using theinhaler and then determine an additional amount of active agent 214 thatshould be delivered to the subject to reach a predetermined dosagelevel. The control unit 108 may then control the operation of an aerosolcanister content release mechanism 270 to facilitate at least partialrelease from an active agent reservoir 212 to deliver an active agent214 to the subject to reach the predetermined dosage level.

FIG. 6B illustrates a partial cross-sectional side view of system 600.System 600 is shown as an embodiment of an inhaler that is activated toat least partially release an incentive agent 218 from an incentiveagent reservoir 216. System 600 includes a housing 102 having a flowchannel 104 disposed therein. Also illustrated are two ports 106disposed in the housing 102 and in fluid communication with the flowchannel 104. An active agent reservoir 212 is illustrated as beingoperably coupled to one of the ports 106. An incentive agent reservoir216 is illustrated as being operably coupled to the other port 106. Theactive agent reservoir 212 and the incentive agent reservoir 216 areillustrated as being held within a reservoir support 192. The activeagent reservoir 212 and the incentive agent reservoir 216 are bothconfigured as aerosol canisters that include a canister body and a valvestem that extends from the canister body into each of the ports 106. Theactive agent reservoir 212 includes a controllable valve 258. Theincentive agent reservoir 216 also includes a controllable valve 258.The controllable valve 258 that is operably coupled to the active agentreservoir 212 is illustrated as being closed as indicated by a closedcircle. The controllable valve 258 that is operably coupled to theincentive agent reservoir 216 is illustrated as being open as indicatedby an open circle. Flow through the flow channel 104 is illustrated byone arrow indicating directional flow through the flow channel 104 fromright to left toward the mouthpiece 268 and indicates an inhalationcycle of a subject using the inhaler.

A flow sensor 124 is operably coupled to the flow channel 104 andconfigured to detect flow through the flow channel 104. An aerosolcanister content release mechanism 270 is illustrated with a pushrodactuator 256 operably coupled with each of the active agent reservoir212 and the incentive agent reservoir 216. The aerosol canister contentrelease mechanism 270 is operably coupled with a control unit 108. Thecontrol unit 108 is configured to direct operation of the aerosolcanister content release mechanism 270 to control each of the pushrodactuators 256 to facilitate at least partial release from each of theactive agent reservoir 212 and the incentive agent reservoir 216.Accordingly, in some embodiments, the control unit 108 may be configuredto facilitate at least partial release from one or both of the activeagent reservoir 212 and the incentive agent reservoir 216. The controlunit 108 is operably coupled with the flow sensor 124. Accordingly, insome embodiments, the control unit 108 may be configured to facilitateat least partial release from one or both of the active agent reservoir212 and the incentive agent reservoir 216. In some embodiments, thecontrol unit 108 may be configured to facilitate at least partialrelease from one or both of the active agent reservoir 212 and theincentive agent reservoir 216 during an inhalation cycle. In someembodiments, the control unit 108 may be configured to halt at leastpartial release from one or both of the active agent reservoir 212 andthe incentive agent reservoir 216 during an exhalation cycle.

Again, as noted above, in some embodiments, an inhaler may include anoperably coupled performance indicator 116. The performance indicator116 in FIG. 6B is illustrated as indicating a high level of respirationperformance as compared to the respiration performance indicated in FIG.6. In some embodiments a control unit 108 may be configured to controlthe operation of an aerosol canister content release mechanism 270 tofacilitate release of an incentive agent 218 from an incentive agentreservoir 216 when one or more measured parameters related torespiration performance meet or exceed a threshold value. Accordingly,in FIG. 6B the pushrod actuator 256 that is operably coupled to theincentive agent reservoir 216 is shown as being activated to at leastpartially release an incentive agent 218 from the incentive agentreservoir 216 in response to the high level of respiration performance.An optical sensor 126 is illustrated as being operably coupled with theflow channel 104. In some embodiments, an optical sensor 126 may beconfigured to determine a quantity of either or both of an active agent214 and an incentive agent 218 that flows through the flow channel 104.Accordingly, in some embodiments, an optical sensor 126 may be operablycoupled with a control unit 108 that is configured to determine aquantity of an incentive agent 218 that is delivered to a subject usingthe inhaler and then determine an additional amount of an incentiveagent 218 that should be delivered to the subject to reach apredetermined administration level. The control unit 108 may thencontrol the operation of an aerosol canister content release mechanism270 to facilitate at least partial release from one or more incentiveagent reservoirs 216 to deliver one or more incentive agents 218 to thesubject to reach the predetermined dosage level.

FIG. 7 illustrates a partial cross-sectional side view of system 700that is configured as an embodiment of an inhaler. System 700 includes ahousing 102 having a flow channel 104 disposed therein. Also illustratedare two ports 106 disposed in the housing 102 and in fluid communicationwith the flow channel 104. An active agent reservoir 212 is illustratedas being aligned with one of the ports 106. An incentive agent reservoir216 is illustrated as being operably coupled to the other port 106. Theactive agent reservoir 212 and the incentive agent reservoir 216 areillustrated as being held within a reservoir support 192. The activeagent reservoir 212 includes a conveyor with a conveying driveconfigured to advance a blister strip that includes a plurality ofblister packs that are filled with a powdered active agent 214. Theconveyor of the active agent reservoir 212 is configured to advance theblister packs past a blister pack puncture mechanism 272. The blisterpack puncture mechanism 272 is illustrated as including a pushrodactuator 256 that is configured to puncture a blister pack and propelthe powdered active agent 214 contained within the blister pack throughport 106 and into the flow channel 104. The incentive agent reservoir216 is configured as an aerosol canister that includes a canister bodyand a valve stem that extends from the canister body into a port 106.The incentive agent reservoir 216 includes a controllable valve 258. Thecontrollable valve 258 is illustrated as being closed as indicated by aclosed circle. An aerosol canister content release mechanism 270 isoperably coupled with the incentive agent reservoir 216 and includes apushrod actuator 256 that is configured to facilitate at least partialrelease of incentive agent 218 from the incentive agent reservoir 216.Flow through the flow channel 104 is illustrated by the two arrowsindicating directional flow through the flow channel 104. Flow fromright to left toward the mouthpiece 268 is related to an inhalationcycle of a subject using the inhaler. Flow from left to right away fromthe mouthpiece 268 is related to an exhalation cycle of a subject usingthe inhaler. A flow sensor 124 is operably coupled to the flow channel104 and configured to detect flow through the flow channel 104.

The aerosol canister content release mechanism 270 is operably coupledwith a control unit 108. The blister pack puncture mechanism 272 isoperably coupled with a control unit 108. The control unit 108 isconfigured to direct operation of the aerosol canister content releasemechanism 270. The control unit 108 is configured to direct operation ofthe blister pack puncture mechanism 272. Accordingly, in someembodiments, the control unit 108 may be configured to facilitate atleast partial release from one or both of the active agent reservoir 212and the incentive agent reservoir 216. The control unit 108 is operablycoupled with the flow sensor 124. In some embodiments, the control unit108 may be configured to facilitate at least partial release from one orboth of the active agent reservoir 212 and the incentive agent reservoir216 during an inhalation cycle. In some embodiments, the control unit108 may be configured to halt at least partial release from one or bothof the active agent reservoir 212 and the incentive agent reservoir 216during an exhalation cycle. In some embodiments, the control unit 108may be configured to facilitate at least partial release from an activeagent reservoir 212 and then facilitate at least partial release from anincentive agent reservoir 216. In some embodiments, the control unit 108may be configured to facilitate at least partial release from anincentive agent reservoir 216 and then facilitate at least partialrelease from an active agent reservoir 212. In some embodiments, thecontrol unit 108 may be configured to facilitate at least partialrelease from both the incentive agent reservoir 216 and from the activeagent reservoir 212 at substantially the same time. In some embodiments,the flow sensor 124 may be configured to detect a quantity of activeagent 214 that is included in the exhalant of a subject using theinhaler. Accordingly, in some embodiments, such information may betransmitted to the control unit 108 that may use the information tocalculate a quantity of the active agent 214 that needs to beadministered to the subject to reach a predetermined dosage. The controlunit 108 may then control the operation of the blister pack puncturemechanism 272 to administer an additional amount of the active agent 214to reach the predetermined dosage.

FIG. 7A illustrates a partial cross-sectional side view of system 700that is configured as an embodiment of an inhaler that is activated toat least partially release active agent 214 from an active agentreservoir 212. System 700 includes a housing 102 having a flow channel104 disposed therein. Also illustrated are two ports 106 disposed in thehousing 102 and in fluid communication with the flow channel 104. Anactive agent reservoir 212 is illustrated as being aligned with one ofthe ports 106. An incentive agent reservoir 216 is illustrated as beingoperably coupled to the other port 106. The active agent reservoir 212and the incentive agent reservoir 216 are illustrated as being heldwithin a reservoir support 192. The active agent reservoir 212 includesa conveyor with a conveying drive configured to advance a blister stripthat includes a plurality of blister packs that are filled with apowdered active agent 214. The conveyor of the active agent reservoir212 is configured to advance the blister packs past a blister packpuncture mechanism 272. The blister pack puncture mechanism 272 isillustrated as having a pushrod actuator 256 that is configured topuncture a blister pack and propel the powdered active agent 214contained within the blister pack through port 106 and into the flowchannel 104.

In some embodiments, the incentive agent reservoir 216 is configured asan aerosol canister that includes a canister body and a valve stem thatextends from the canister body into a port 106. The incentive agentreservoir 216 includes a controllable valve 258. The controllable valve258 is illustrated as being closed as indicated by a closed circle. Anaerosol canister content release mechanism 270 is operably coupled withthe incentive agent reservoir 216 and includes a pushrod actuator 256that is configured to facilitate at least partial release of incentiveagent 218 from the incentive agent reservoir 216. Flow through the flowchannel 104 is illustrated by an arrow indicating flow from right toleft toward the mouthpiece 268. This flow is related to an inhalationcycle of a subject using the inhaler. A flow sensor 124 is operablycoupled to the flow channel 104 and configured to detect flow throughthe flow channel 104. The blister pack puncture mechanism 272 and theaerosol canister content release mechanism 270 are each operably coupledto a control unit 108. Accordingly, in some embodiments, the controlunit 108 may direct operation of the blister pack puncture mechanism 272to facilitate at least partial release of active agent 214 from anactive agent reservoir 212. In some embodiments, the control unit 108may direct operation of the aerosol canister release mechanism 270 tofacilitate at least partial release of incentive agent 218 from anincentive agent reservoir 216.

The control unit 108 is operably coupled with the flow sensor 124. Insome embodiments, the control unit 108 may be configured to facilitateat least partial release from one or both of the active agent reservoir212 and the incentive agent reservoir 216 during an inhalation cycle. Insome embodiments, the control unit 108 may be configured to halt atleast partial release from one or both of the active agent reservoir 212and the incentive agent reservoir 216 during an exhalation cycle. Insome embodiments, the control unit 108 may be configured to facilitateat least partial release from an active agent reservoir 212 and thenfacilitate at least partial release from an incentive agent reservoir216. In some embodiments, the control unit 108 may be configured tofacilitate at least partial release from an incentive agent reservoir216 and then facilitate at least partial release from an active agentreservoir 212. In some embodiments, the control unit 108 may beconfigured to facilitate at least partial release from both theincentive agent reservoir 216 and from the active agent reservoir 212 atsubstantially the same time. In some embodiments, the flow sensor 124may be configured to detect a quantity of an active agent 214 that isincluded in the exhalant of a subject using the inhaler. Accordingly, insome embodiments, such information may be transmitted to the controlunit 108 that may use the information to calculate a quantity of theactive agent 214 that needs to be administered to the subject to reach apredetermined dosage. The control unit 108 may then control operation ofthe blister pack puncture mechanism 272 to administer an additionalamount of the active agent 214 to reach the predetermined dosage.

FIG. 7B illustrates a partial cross-sectional side view of system 700that is configured as an embodiment of an inhaler that is activated toat least partially release an incentive agent 218 from an incentiveagent reservoir 216. System 700 includes a housing 102 having a flowchannel 104 disposed therein. Also illustrated are two ports 106disposed in the housing 102 and in fluid communication with the flowchannel 104. An active agent reservoir 212 is illustrated as beingaligned with one of the ports 106. An incentive agent reservoir 216 isillustrated as being operably coupled to the other port 106. The activeagent reservoir 212 and the incentive agent reservoir 216 areillustrated as being held within a reservoir support 192. The activeagent reservoir 212 includes a conveyor with a conveying driveconfigured to advance a blister strip that includes a plurality ofblister packs that are filled with a powdered active agent 214. Theconveyor of the active agent reservoir 212 is configured to advance theblister packs past a blister pack puncture mechanism 272. The blisterpack puncture mechanism 272 is illustrated as including a pushrodactuator 256 that is configured to puncture a blister pack and propelthe powdered active agent 214 contained within the blister pack throughport 106 and into the flow channel 104.

In some embodiments, the incentive agent reservoir 216 is configured asan aerosol canister that includes a canister body and a valve stem thatextends from the canister body into a port 106. The incentive agentreservoir 216 includes a controllable valve 258. An aerosol canistercontent release mechanism 270 is operably coupled with the incentiveagent reservoir 216 and includes a pushrod actuator 256 that isconfigured to facilitate at least partial release of incentive agent 218from the incentive agent reservoir 216. The controllable valve 258 isillustrated as being open as indicated by an open circle thatfacilitates at least partial release of an incentive agent 218 throughthe port 106 and into the flow channel 104. Flow through the flowchannel 104 is illustrated by an arrow indicating flow from right toleft toward the mouthpiece 268. This flow is related to an inhalationcycle of a subject using the inhaler. A flow sensor 124 is operablycoupled to the flow channel 104 and configured to detect flow throughthe flow channel 104. The blister pack puncture mechanism 272 and theaerosol canister content release mechanism 270 are each operably coupledto a control unit 108. Accordingly, in some embodiments, the controlunit 108 may direct operation of the blister pack puncture mechanism 272to facilitate at least partial release of active agent 214 from anactive agent reservoir 212. In some embodiments, the control unit 108may direct operation of the aerosol canister release mechanism 270 tofacilitate at least partial release of incentive agent 218 from anincentive agent reservoir 216. The control unit 108 is operably coupledwith the flow sensor 124. Accordingly, in some embodiments, the controlunit 108 may be configured to facilitate at least partial release fromone or both of the active agent reservoir 212 and the incentive agentreservoir 216. In some embodiments, the control unit 108 may beconfigured to facilitate at least partial release from one or both ofthe active agent reservoir 212 and the incentive agent reservoir 216during an inhalation cycle. In some embodiments, the control unit 108may be configured to halt at least partial release from one or both ofthe active agent reservoir 212 and the incentive agent reservoir 216during an exhalation cycle. In some embodiments, the control unit 108may be configured to facilitate at least partial release from an activeagent reservoir 212 and then facilitate at least partial release from anincentive agent reservoir 216. In some embodiments, the control unit 108may be configured to facilitate at least partial release from anincentive agent reservoir 216 and then facilitate at least partialrelease from an active agent reservoir 212. In some embodiments, thecontrol unit 108 may be configured to facilitate at least partialrelease from both the incentive agent reservoir 216 and from the activeagent reservoir 212 at substantially the same time. In some embodiments,the flow sensor 124 may be configured to detect a quantity of anincentive agent 218 that is included in the exhalant of a subject usingthe inhaler. Accordingly, in some embodiments, such information may betransmitted to the control unit 108 that may use the information tocalculate a quantity of the incentive agent 218 that needs to beadministered to the subject to reach a predetermined dosage. The controlunit 108 may then control the operation of an aerosol canister releasemechanism 270 to administer an additional amount of the incentive agent218 to reach the predetermined dosage.

FIG. 8 illustrates a partial cross-sectional side view of system 800that is configured as an embodiment of an inhaler that is activated toat least partially release active agent 214 from an active agentreservoir 212. System 800 includes a housing 102 having a flow channel104 disposed therein. Also illustrated are two ports 106 disposed in thehousing 102 and in fluid communication with the flow channel 104. Anactive agent reservoir 212 is illustrated as being aligned with one ofthe ports 106. An incentive agent reservoir 216 is illustrated as beingoperably coupled to the other port 106. The active agent reservoir 212and the incentive agent reservoir 216 are illustrated as being heldwithin a reservoir support 192. The active agent reservoir 212 includesa conveyor with a conveying drive configured to advance a blister stripthat includes a plurality of blister packs that are filled with apowdered active agent 214. The conveyor of the active agent reservoir212 is configured to advance the blister packs past a blister packpuncture mechanism 272. The blister pack puncture mechanism 272 isillustrated as having an activated pushrod actuator 256 that punctured ablister pack and propelled the powdered active agent 214 containedwithin the blister pack through port 106 and into the flow channel 104.The incentive agent reservoir 216 is configured as an aerosol canisterthat includes a canister body and a valve stem that extends from thecanister body into a port 106. The incentive agent reservoir 216includes a controllable valve 258. The controllable valve 258 isillustrated as being closed as indicated by a closed circle. An aerosolcanister content release mechanism 270 is operably coupled with theincentive agent reservoir 216 and includes a pushrod actuator 256 thatis configured to facilitate at least partial release of incentive agent218 from the incentive agent reservoir 216. Flow through the flowchannel 104 is illustrated by an arrow indicating flow from right toleft toward the mouthpiece 268. This flow is related to an inhalationcycle of a subject using the inhaler. A flow sensor 124 is operablycoupled to the flow channel 104 and configured to detect flow throughthe flow channel 104. The blister pack puncture mechanism 272 and theaerosol canister content release mechanism 270 are each operably coupledto a control unit 108. Accordingly, in some embodiments, the controlunit 108 may direct operation of the blister pack puncture mechanism 272to facilitate at least partial release of active agent 214 from anactive agent reservoir 212. In some embodiments, the control unit 108may direct operation of the aerosol canister release mechanism 270 tofacilitate at least partial release of incentive agent 218 from anincentive agent reservoir 216. The control unit 108 is operably coupledwith the flow sensor 124. In some embodiments, the control unit 108 maybe configured to facilitate at least partial release from one or both ofthe active agent reservoir 212 and the incentive agent reservoir 216during an inhalation cycle. In some embodiments, the control unit 108may be configured to halt at least partial release from one or both ofthe active agent reservoir 212 and the incentive agent reservoir 216during an exhalation cycle. In some embodiments, the control unit 108may be configured to facilitate at least partial release from an activeagent reservoir 212 and then facilitate at least partial release from anincentive agent reservoir 216. In some embodiments, the control unit 108may be configured to facilitate at least partial release from anincentive agent reservoir 216 and then facilitate at least partialrelease from an active agent reservoir 212. In some embodiments, thecontrol unit 108 may be configured to facilitate at least partialrelease from both the incentive agent reservoir 216 and from the activeagent reservoir 212 at substantially the same time. In some embodiments,the flow sensor 124 may be configured to detect a quantity of an activeagent 214 that is included in the exhalant of a subject using theinhaler. Accordingly, in some embodiments, such information may betransmitted to the control unit 108 that may use the information tocalculate a quantity of the active agent 214 that needs to beadministered to the subject to reach a predetermined dosage. The controlunit 108 may then control the operation of the blister pack puncturemechanism 272 to administer an additional amount of the active agent 214to reach the predetermined dosage.

In some embodiments, an inhaler may include an operably coupledperformance indicator 116. The performance indicator 116 in FIG. 8 isillustrated as indicating a high level of respiration performance. Insome embodiments a control unit 108 may be configured to control theoperation of a blister pack puncture mechanism 272 to facilitate releaseof an active agent 214 from an active agent reservoir 212 when one ormore assessed parameters related to respiration performance meet orexceed a threshold value. Accordingly, in FIG. 8 the blister packpuncture mechanism 272 is shown as being activated to puncture a blisterpack and propel a powdered active agent 214 through a port 106 and intoa flow channel 104 in response to the high level of respirationperformance. An optical sensor 126 is illustrated as being operablycoupled with the flow channel 104. In some embodiments, an opticalsensor 126 may be configured to determine a quantity of either or bothof an active agent 214 and an incentive agent 218 that flows through theflow channel 104. Accordingly, in some embodiments, an optical sensor126 may be operably coupled with a control unit 108 that is configuredto determine a quantity of an active agent 214 that is delivered to asubject using the inhaler and then determine an additional amount ofactive agent 214 that should be delivered to the subject to reach apredetermined administration level. The control unit 108 may thencontrol the blister pack puncture mechanism 272 to facilitate at leastpartial release from one or more active agent reservoirs 212 to deliveractive agent 214 to the subject to reach the predetermined dosage level.

FIG. 8A illustrates a partial cross-sectional side view of system 800that is configured as an embodiment of an inhaler that is activated toat least partially release an incentive agent 218 from an incentiveagent reservoir 216. System 800 includes a housing 102 having a flowchannel 104 disposed therein. Also illustrated are two ports 106disposed in the housing 102 and in fluid communication with the flowchannel 104. An active agent reservoir 212 is illustrated as beingaligned with one of the ports 106. An incentive agent reservoir 216 isillustrated as being operably coupled to the other port 106. The activeagent reservoir 212 and the incentive agent reservoir 216 areillustrated as being held within a reservoir support 192. The activeagent reservoir 212 includes a conveyor with a conveying driveconfigured to advance a blister strip that includes a plurality ofblister packs that are filled with a powdered active agent 214. Theconveyor of the active agent reservoir 212 is configured to advance theblister packs past a blister pack puncture mechanism 272. The blisterpack puncture mechanism 272 is illustrated as having a pushrod actuator256. The incentive agent reservoir 216 is configured as an aerosolcanister that includes a canister body and a valve stem that extendsfrom the canister body into a port 106. The incentive agent reservoir216 includes a controllable valve 258. The controllable valve 258 isillustrated as being open as indicated by an open circle facilitatingrelease of an incentive agent 218 through a port 106 and into the flowchannel 104. Flow through the flow channel 104 is illustrated by anarrow indicating flow from right to left toward the mouthpiece 268. Thisflow is related to an inhalation cycle of a subject using the inhaler. Aflow sensor 124 is operably coupled to the flow channel 104 andconfigured to detect flow through the flow channel 104. An aerosolcanister content release mechanism 270 is illustrated as being operablycoupled with the incentive agent reservoir 216. The blister packpuncture mechanism 272 and the aerosol canister content releasemechanism 270 are each operably coupled to a control unit 108.

Accordingly, in some embodiments, the control unit 108 may directoperation of the blister pack puncture mechanism 272 to facilitate atleast partial release of active agent 214 from an active agent reservoir212. In some embodiments, the control unit 108 may direct operation ofthe aerosol canister release mechanism 270 to facilitate at leastpartial release of incentive agent 218 from an incentive agent reservoir216. The control unit 108 is operably coupled with the flow sensor 124.In some embodiments, the control unit 108 may be configured tofacilitate at least partial release from one or both of the active agentreservoir 212 and the incentive agent reservoir 216 during an inhalationcycle. In some embodiments, the control unit 108 may be configured tohalt at least partial release from one or both of the active agentreservoir 212 and the incentive agent reservoir 216 during an exhalationcycle. In some embodiments, the control unit 108 may be configured tofacilitate at least partial release from an active agent reservoir 212and then facilitate at least partial release from an incentive agentreservoir 216. In some embodiments, the control unit 108 may beconfigured to facilitate at least partial release from an incentiveagent reservoir 216 and then facilitate at least partial release from anactive agent reservoir 212. In some embodiments, the control unit 108may be configured to facilitate at least partial release from both theincentive agent reservoir 216 and from the active agent reservoir 212 atsubstantially the same time.

In some embodiments, the flow sensor 124 may be configured to detect aquantity of an active agent 214 that is included in the exhalant of asubject using the inhaler. Accordingly, in some embodiments, suchinformation may be transmitted to the control unit 108 that may use theinformation to calculate a quantity of the active agent 214 that needsto be administered to the subject to reach a predetermined dosage. Thecontrol unit 108 may then control the operation of a blister packpuncture mechanism 272 to administer an additional amount of the activeagent 214 to reach the predetermined dosage.

In some embodiments, an inhaler may include an operably coupledperformance indicator 116. The performance indicator 116 in FIG. 8A isillustrated as indicating a high level of respiration performance. Insome embodiments a control unit 108 may be configured to control theoperation of an aerosol canister content release mechanism 270 tofacilitate release of an incentive agent 218 from an incentive agentreservoir 216 when one or more measured parameters related torespiration performance meet or exceed a threshold value. Accordingly,in FIG. 8A the pushrod actuator 256 that is operably coupled to theincentive agent reservoir 216 is shown as being activated to compressthe canister body of the incentive agent reservoir 216 against the valvestem to facilitate at least partial release of the incentive agent 218through a port 106 and into a flow channel 104 in response to the highlevel of respiration performance. An optical sensor 126 is illustratedas being operably coupled with the flow channel 104. In someembodiments, an optical sensor 126 may be configured to determine aquantity of either or both of an active agent 214 and an incentive agent218 that flows through the flow channel 104. Accordingly, in someembodiments, an optical sensor 126 may be operably coupled with acontrol unit 108 that is configured to determine a quantity of anincentive agent 218 that is delivered to a subject using the inhaler andthen determine an additional amount of an incentive agent 218 thatshould be delivered to the subject to reach a predeterminedadministration level. The control unit 108 may then control theoperation of an aerosol canister content release mechanism 270 tofacilitate at least partial release from one or more incentive agentreservoirs 216 to deliver an incentive agent 218 to the subject to reachthe predetermined dosage level.

FIG. 9 illustrates a partial cross-sectional side view of system 900that is configured as an embodiment of an inhaler. System 900 includes ahousing 102 having a flow channel 104 disposed therein. Also illustratedis one port 106 disposed in the housing 102 and in fluid communicationwith the flow channel 104. An active agent reservoir 212 is illustratedas being operably coupled to the port 106. An incentive agent reservoir216 is illustrated as being operably coupled to the port 106. The activeagent reservoir 212 and the incentive agent reservoir 216 areillustrated as being held within a reservoir support 192. The activeagent reservoir 212 and the incentive agent reservoir 216 are bothconfigured as aerosol canisters that include a canister body and a valvestem that extends from the canister body into the port 106. The activeagent reservoir 212 includes a controllable valve 258. The incentiveagent reservoir 216 also includes a controllable valve 258. Both of thecontrollable valves 258 are illustrated as being closed as indicated bya closed circle. The active agent reservoir 212 and the incentive agentreservoir 216 are both operably coupled with an aerosol canister contentrelease mechanism 270. The aerosol canister content release mechanism270 includes two pushrod actuators 256. One of the pushrod actuators 256is operably coupled with the active agent reservoir 212 and the otherpushrod actuator 256 is operably coupled to the incentive agentreservoir 216.

Flow through the flow channel 104 is illustrated by the two arrowsindicating directional flow through the flow channel 104. Flow fromright to left toward the mouthpiece 268 is related to an inhalationcycle of a subject using the inhaler. Flow from left to right away fromthe mouthpiece 268 is related to an exhalation cycle of a subject usingthe inhaler. A flow sensor 124 is operably coupled to the flow channel104 and configured to detect flow through the flow channel 104. Theaerosol canister content release mechanism 270 is operably coupled witha control unit 108 that is configured to direct the operation of each ofthe pushrod actuators 256 to facilitate at least partial release fromeach of the active agent reservoir 212 and the incentive agent reservoir216. The control unit 108 is operably coupled with the flow sensor 124.In some embodiments, the control unit 108 may be configured tofacilitate at least partial release from one or both of the active agentreservoir 212 and the incentive agent reservoir 216 during an inhalationcycle. In some embodiments, the control unit 108 may be configured tohalt at least partial release from one or both of the active agentreservoir 212 and the incentive agent reservoir 216 during an exhalationcycle. In some embodiments, the control unit 108 may be configured tofacilitate at least partial release from an active agent reservoir 212and then facilitate at least partial release from an incentive agentreservoir 216. In some embodiments, the control unit 108 may beconfigured to facilitate at least partial release from an incentiveagent reservoir 216 and then facilitate at least partial release from anactive agent reservoir 212. In some embodiments, the control unit 108may be configured to facilitate at least partial release from both theincentive agent reservoir 216 and from the active agent reservoir 212 atsubstantially the same time.

FIG. 9A illustrates a partial cross-sectional side view of system 900that is configured as an embodiment of an inhaler that is activated toat least partially release an active agent 214 from an active agentreservoir 212. System 900 includes a housing 102 having a flow channel104 disposed therein. Also illustrated is one port 106 disposed in thehousing 102 and in fluid communication with the flow channel 104. Anactive agent reservoir 212 is illustrated as being operably coupled tothe port 106. An incentive agent reservoir 216 is illustrated as beingoperably coupled to the port 106. The active agent reservoir 212 and theincentive agent reservoir 216 are illustrated as being held within areservoir support 192. The active agent reservoir 212 and the incentiveagent reservoir 216 are both configured as aerosol canisters thatinclude a canister body and a valve stem that extends from the canisterbody into the port 106. The active agent reservoir 212 includes acontrollable valve 258. The incentive agent reservoir 216 also includesa controllable valve 258. The controllable valve 258 that is operablycoupled to the active agent reservoir 212 is illustrated as being opento facilitate release of active agent 214 from the active agentreservoir 212 into the flow channel 104 as indicated by an open circle.The controllable valve 258 that is operably coupled to the incentiveagent reservoir 216 is illustrated as being closed as indicated by aclosed circle.

The active agent reservoir 212 and the incentive agent reservoir 216 areboth operably coupled with an aerosol canister content release mechanism270. The aerosol canister content release mechanism 270 includes twopushrod actuators 256. One of the pushrod actuators 256 is operablycoupled with the active agent reservoir 212 and the other pushrodactuator 256 is operably coupled to the incentive agent reservoir 216.Flow through the flow channel 104 is illustrated by the arrow indicatingright to left flow through the flow channel 104. Flow from right to lefttoward the mouthpiece 268 is related to an inhalation cycle of a subjectusing the inhaler. A flow sensor 124 is operably coupled to the flowchannel 104 and configured to detect flow through the flow channel 104.The aerosol canister content release mechanism 270 is operably coupledwith a control unit 108 that is configured to direct the operation ofeach of the pushrod actuators 256 to facilitate at least partial releasefrom each of the active agent reservoir 212 and the incentive agentreservoir 216. The control unit 108 is operably coupled with the flowsensor 124. Accordingly, in some embodiments, the control unit 108 maybe configured to facilitate at least partial release from one or both ofthe active agent reservoir 212 and the incentive agent reservoir 216. Insome embodiments, the control unit 108 may be configured to facilitateat least partial release from one or both of the active agent reservoir212 and the incentive agent reservoir 216 during an inhalation cycle. Insome embodiments, the control unit 108 may be configured to halt atleast partial release from one or both of the active agent reservoir 212and the incentive agent reservoir 216 during an exhalation cycle.

FIG. 9B illustrates a partial cross-sectional side view of system 900that is configured as an embodiment of an inhaler that is activated toat least partially release an incentive agent 218 from an incentiveagent reservoir 216. System 900 includes a housing 102 having a flowchannel 104 disposed therein. Also illustrated is one port 106 disposedin the housing 102 and in fluid communication with the flow channel 104.An active agent reservoir 212 is illustrated as being operably coupledto the port 106. An incentive agent reservoir 216 is illustrated asbeing operably coupled to the port 106. The active agent reservoir 212and the incentive agent reservoir 216 are illustrated as being heldwithin a reservoir support 192. The active agent reservoir 212 and theincentive agent reservoir 216 are both configured as aerosol canistersthat include a canister body and a valve stem that extends from thecanister body into the port 106. The active agent reservoir 212 includesa controllable valve 258. The incentive agent reservoir 216 alsoincludes a controllable valve 258. The controllable valve 258 that isoperably coupled to the incentive agent reservoir 216 is illustrated asbeing open to facilitate release of an incentive agent 218 from theincentive agent reservoir 216 into the flow channel 104 as indicated byan open circle. The controllable valve 258 that is operably coupled tothe active agent reservoir 212 is illustrated as being closed asindicated by a closed circle. The active agent reservoir 212 and theincentive agent reservoir 216 are both operably coupled with an aerosolcanister content release mechanism 270. The aerosol canister contentrelease mechanism 270 includes two pushrod actuators 256. One of thepushrod actuators 256 is operably coupled with the active agentreservoir 212 and the other pushrod actuator 256 is operably coupled tothe incentive agent reservoir 216.

Flow through the flow channel 104 is illustrated by the arrow indicatingright to left flow through the flow channel 104. Flow from right to lefttoward the mouthpiece 268 is related to an inhalation cycle of a subjectusing the inhaler. A flow sensor 124 is operably coupled to the flowchannel 104 and configured to detect flow through the flow channel 104.The aerosol canister content release mechanism 270 is operably coupledwith a control unit 108 that is configured to direct the operation ofeach of the pushrod actuators 256 to facilitate at least partial releasefrom each of the active agent reservoir 212 and the incentive agentreservoir 216. The control unit 108 is operably coupled with the flowsensor 124. Accordingly, in some embodiments, the control unit 108 maybe configured to facilitate at least partial release from one or both ofthe active agent reservoir 212 and the incentive agent reservoir 216. Insome embodiments, the control unit 108 may be configured to facilitateat least partial release from one or both of the active agent reservoir212 and the incentive agent reservoir 216 during an inhalation cycle. Insome embodiments, the control unit 108 may be configured to halt atleast partial release from one or both of the active agent reservoir 212and the incentive agent reservoir 216 during an exhalation cycle.

FIG. 10 illustrates operational flow 1000 that includes operation 1010that includes assessing one or more parameters associated with use of aninhaler by a subject, operation 1020 that includes administering atleast one active agent 214 to the subject in response to assessing theone or more parameters associated with use of the inhaler, and operation1030 that includes administering at least one incentive agent 218 to thesubject in coordination with administering the at least one active agent214.

In FIG. 10 and in the following description that includes variousexamples of operations used during performance of the method, discussionand explanation may be provided with respect to any one or combinationof the above-described examples, and/or with respect to other examplesand contexts. However, it should be understood that the operations maybe executed in a number of other environments and contexts, and/ormodified versions of the figures. Also, although the various operationsare presented in the sequence(s) illustrated, it should be understoodthat the various operations may be performed in other orders than thosewhich are illustrated, or may be performed concurrently.

Operation 1010 includes assessing one or more parameters associated withuse of an inhaler by a subject. In some embodiments, system 100 may beused to assess one or more parameters associated with use of an inhalerby a subject. In some embodiments, components of system 100 may be usedto assess one or more parameters associated with use of an inhaler by asubject. For example, in some embodiments, a sensor 114 may be used toassess one or more parameters associated with use of an inhaler by asubject. In some embodiments, a control unit 108 may be used to assessone or more parameters associated with use of an inhaler by a subject.In some embodiments, a performance indicator 116 may be used to assessone or more parameters associated with use of an inhaler by a subject.In some embodiments, a dose counter 118 may be used to assess one ormore parameters associated with use of an inhaler by a subject. In someembodiments, a user interface 110 may be used to assess one or moreparameters associated with use of an inhaler by a subject. Numerousparameters associated with use of an inhaler may be assessed. Examplesof such parameters include, but are not limited to, parameters relatedto inhalation, exhalation, breath holding, administration of an activeagent 214 to a subject, quantity of an active agent 214 administered toa subject, time when an active agent 214 was administered to a subject,administration of an incentive agent 218 to a subject, quantity of anincentive agent 218 administered to a subject, time when an incentiveagent 218 was administered to a subject, and the like.

Operation 1020 includes administering at least one active agent 214 tothe subject in response to assessing the one or more parametersassociated with use of the inhaler. In some embodiments, system 100 maybe used to administer at least one active agent 214 to a subject inresponse to assessing one or more parameters associated with use of aninhaler. In some embodiments, components of system 100 may be used toadminister at least one active agent 214 to a subject in response toassessing one or more parameters associated with use of an inhaler. Forexample, in some embodiments, an actuator 120 may be activated tofacilitate at least partial release of an active agent 214 from anactive agent reservoir 212. In some embodiments, a blister pack puncturemechanism 272 may be activated to facilitate at least partial release ofan active agent 214 from an active agent reservoir 212. In someembodiments, an aerosol canister content release mechanism 270 may beactivated to facilitate at least partial release of an active agent 214from an active agent reservoir 212. In some embodiments, an actuator 120that is operably coupled with a control unit 108 may be activated tofacilitate at least partial release of an active agent 214 from anactive agent reservoir 212. In some embodiments, a control unit 108 mayreceive information that is related to one or more respirationparameters from an operably coupled sensor 114 and then activate one ormore operably coupled actuators 120 to facilitate at least partialrelease of an active agent 214 from an active agent reservoir 212. Insome embodiments, a user interface 110 may be used to direct an operablycoupled actuator 120 to facilitate at least partial release of an activeagent 214 from an active agent reservoir 212. In some embodiments, aperformance indicator 116 may be used to direct an operably coupledactuator 120 to facilitate at least partial release of an active agent214 from an active agent reservoir 212. Accordingly, numerouscombinations of components included within system 100 may be used toadminister at least one active agent 214 to a subject.

Operation 1030 includes administering at least one incentive agent 218to the subject in coordination with administering the at least oneactive agent 214. In some embodiments, system 100 may be used toadminister at least one incentive agent 218 to the subject incoordination with administering at least one active agent 214. In someembodiments, components of system 100 may be used to administer at leastone incentive agent 218 to the subject in coordination withadministering at least one active agent 214. For example, in someembodiments, an actuator 120 may be activated to administer at least oneincentive agent 218 to a subject. In some embodiments, a blister packpuncture mechanism 272 may be activated to facilitate at least partialrelease of an incentive agent 218 from an incentive agent reservoir 216.In some embodiments, an aerosol canister content release mechanism 270may be activated to facilitate at least partial release of an incentiveagent 218 from an incentive agent reservoir 216. In some embodiments, anactuator 120 that is operably coupled with a control unit 108 may beactivated to administer at least one incentive agent 218 to a subject.In some embodiments, a control unit 108 may receive information that isrelated to one or more respiration parameters from an operably coupledsensor 114 and then activate one or more operably coupled actuators 120to administer at least one incentive agent 218 to a subject. In someembodiments, a user interface 110 may be used to direct an operablycoupled actuator 120 to administer at least one incentive agent 218 to asubject. In some embodiments, a performance indicator 116 may be used todirect an operably coupled actuator 120 to administer at least oneincentive agent 218 to a subject. Accordingly, numerous combinations ofcomponents included within system 100 may be used to administer at leastone incentive agent 218 to a subject.

In some embodiments, operation 1010 includes assessing one or moreparameters associated with respiration (not shown). In some embodiments,system 100 may be used to assess one or more parameters associated withrespiration. For example, in some embodiments, one or more sensors 114may be configured to assess one or more parameters associated withrespiration. In some embodiments, one or more control units 108 may beconfigured to assess one or more parameters associated with respiration.Numerous parameters associated with respiration by a subject using aninhaler may be assessed. Examples of such parameters include, but arenot limited to, time associated with an inhalation cycle, timeassociated with an exhalation cycle, time associated with a breath holdcycle, volume of flow inhaled through a flow channel 104, volume of flowexhaled through a flow channel 104, velocity of flow through a flowchannel 104, and the like.

In some embodiments, operation 1010 includes assessing one or moreparameters associated with inhalation (not shown). In some embodiments,system 100 may be used to assess one or more parameters associated withinhalation. For example, in some embodiments, one or more sensors 114may be configured to assess one or more parameters associated withinhalation. In some embodiments, one or more control units 108 may beconfigured to assess one or more parameters associated with inhalation.Numerous parameters associated with inhalation by a subject using aninhaler may be assessed. Examples of such parameters include, but arenot limited to, time associated with an inhalation cycle, volume of flowinhaled through a flow channel 104, velocity of flow through a flowchannel 104 during an inhalation cycle, and the like.

In some embodiments, operation 1010 includes assessing one or moreparameters associated with exhalation (not shown). In some embodiments,system 100 may be used to assess one or more parameters associated withexhalation. For example, in some embodiments, one or more sensors 114may be configured to assess one or more parameters associated withexhalation. In some embodiments, one or more control units 108 may beconfigured to assess one or more parameters associated with exhalation.Numerous parameters associated with exhalation by a subject using aninhaler may be assessed. Examples of such parameters include, but arenot limited to, time associated with an exhalation cycle, volume of flowexhaled through a flow channel 104, velocity of flow through a flowchannel 104 during an exhalation cycle, and the like.

In some embodiments, operation 1010 includes assessing one or moreparameters associated with breath holding (not shown). In someembodiments, system 100 may be used to assess one or more parametersassociated with breath holding. For example, in some embodiments, one ormore sensors 114 may be configured to assess one or more parametersassociated with breath holding. In some embodiments, one or more controlunits 108 may be configured to assess one or more parameters associatedwith breath holding. Numerous parameters associated with breath holdingby a subject using an inhaler may be assessed. Examples of suchparameters include, but are not limited to, time associated with abreath holding cycle, volume of flow inhaled through a flow channel 104and held during a breath holding cycle, velocity of flow through a flowchannel 104 during an inhalation cycle prior to a breath holding cycle,and the like.

In some embodiments, operation 1010 includes assessing one or morevolumes of gas flowing through the inhaler (not shown). In someembodiments, system 100 may be used to assess one or more volumes of gasflowing through the inhaler. For example, in some embodiments, one ormore sensors 114 may be configured as a volume sensor 128 to assess oneor more volumes of gas flowing through one or more flow channels 104disposed within an inhaler.

In some embodiments, operation 1010 includes assessing a velocity withwhich gas flows through the inhaler (not shown). In some embodiments,system 100 may be used to assess a velocity with which gas flows throughan inhaler. In some embodiments, one or more sensors 114 may beconfigured to assess a velocity with which gas flows through one or moreflow channels disposed within the inhaler. For example, in someembodiments, a velocimeter 138 may be used to assess a velocity withwhich gas flows through one or more flow channels 104 disposed within aninhaler.

In some embodiments, operation 1010 includes assessing an amount ofnegative pressure (e.g. vacuum or suction with respect to a surroundingatmospheric pressure) applied to the inhaler by the subject (not shown).In some embodiments, system 100 may be used to assess an amount ofnegative pressure applied to an inhaler by a subject using the inhaler.In some embodiments, one or more sensors 114 may be configured todetermine an amount of negative pressure applied to an inhaler by asubject using the inhaler. For example, in some embodiments, a vacuumsensor 132 may be used to assess an amount of negative pressure appliedto an inhaler by a subject using the inhaler.

In some embodiments, operation 1010 includes assessing a quality ofphysical contact between the subject and the inhaler (not shown). Insome embodiments, system 100 may be used to assess a quality of physicalcontact between a subject and an inhaler used by the subject. In someembodiments, one or more sensors 114 may be configured to assess aquality of physical contact between a subject and an inhaler used by thesubject. For example, in some embodiments, a pressure sensor 130 (e.g.,strain sensor and/or a stress sensor) may be configured to measure anamount of force applied to a mouthpiece of an inhaler used by a subject.

In some embodiments, operation 1010 includes assessing a time periodassociated with any of an inhalation cycle, a breath hold cycle, or anexhalation cycle through the inhaler (not shown). In some embodiments,system 100 may be used to assess a time period associated with any of aninhalation cycle, a breath hold cycle, or an exhalation cycle throughone or more flow channels 104 disposed within an inhaler. In someembodiments, one or more sensors 114 may be configured to assess a timeperiod associated with any of an inhalation cycle, a breath hold cycle,or an exhalation cycle through one or more flow channels 104 disposedwithin an inhaler. For example, in some embodiments, a timer 134 may beused to assess a time period associated with any of an inhalation cycle,a breath hold cycle, or an exhalation cycle through one or more flowchannels 104 disposed within an inhaler.

In some embodiments, operation 1010 includes assessing if at least onevalue associated with a respiration parameter meets or exceeds athreshold value (not shown). In some embodiments, system 100 may be usedto assess if at least one value associated with a respiration parametermeets or exceeds a threshold value. In some embodiments, one or moresensors 114 and one or more control units 108 may be configured toassess if at least one value associated with a respiration parametermeets or exceeds a threshold value. For example, in some embodiments, asensor 114 may be configured as a flow sensor 124 to assess at least onevalue associated with at least one respiration parameter and thentransmit one or more signals that include the value to a control unit108 that determines if the value meets or exceeds a threshold value.Numerous respiration parameters may be assessed to determine if therespiration parameters meet or exceed an associated threshold value.Examples of such respiration parameters include, but are not limited to,volume of flow through one or more flow channels disposed within aninhaler, velocity of flow through one or more flow channels disposedwithin an inhaler, and the like.

In some embodiments, operation 1010 includes assessing if at least onevalue associated with an inhalation parameter meets or exceeds athreshold value (not shown). In some embodiments, system 100 may be usedto assess if at least one value associated with an inhalation parametermeets or exceeds a threshold value. In some embodiments, one or moresensors 114 and one or more control units 108 may be configured toassess if at least one value associated with an inhalation parametermeets or exceeds a threshold value. For example, in some embodiments, asensor 114 may be configured as a flow sensor 124 to assess at least onevalue associated with at least one inhalation parameter and thentransmit one or more signals that include the value to a control unit108 that assesses if the value meets or exceeds a threshold value.Numerous inhalation parameters may be assessed to determine if therespiration parameter meets or exceeds an associated threshold value.Examples of such inhalation parameters include, but are not limited to,volume of flow through one or more flow channels disposed within aninhaler during an inhalation cycle, velocity of flow through one or moreflow channels disposed within an inhaler during an inhalation cycle, andthe like.

In some embodiments, operation 1010 includes assessing if at least onevalue associated with an exhalation parameter meets or exceeds athreshold value (not shown). In some embodiments, system 100 may be usedto assess if at least one value associated with an exhalation parametermeets or exceeds a threshold value. In some embodiments, one or moresensors 114 and one or more control units 108 may be configured todetermine if at least one value associated with an exhalation parametermeets or exceeds a threshold value. For example, in some embodiments, asensor 114 may be configured as a flow sensor 124 to assess at least onevalue associated with at least one exhalation parameter and thentransmit one or more signals that include the value to a control unit108 that assess if the value meets or exceeds a threshold value.Numerous exhalation parameters may be assessed to determine if theexhalation parameter meets or exceeds an associated threshold value.Examples of such exhalation parameters include, but are not limited to,volume of flow through one or more flow channels disposed within aninhaler during an exhalation cycle, velocity of flow through one or moreflow channels disposed within an inhaler during an exhalation cycle, andthe like.

In some embodiments, operation 1010 includes assessing if at least onevalue associated with a breath hold parameter meets or exceeds athreshold value (not shown). In some embodiments, system 100 may be usedto assess if at least one value associated with a breath hold parametermeets or exceeds a threshold value. In some embodiments, one or moresensors 114 and one or more control units 108 may be configured toassess if at least one value associated with a breath hold parametermeets or exceeds a threshold value. For example, in some embodiments, atimer 134 may be used to measure the length of time associated with abreath hold cycle of a subject using an inhaler and then transmit one ormore signals that include the information to a control unit 108 thatassesses if the breath hold value meets or exceeds a threshold value. Insome embodiments, a sensor 114 may be configured as a flow sensor 124 toassess a volume of flow through one or more flow channels disposedwithin an inhaler and held during a breath hold cycle of a subject usingan inhaler and then transmit one or more signals that include theinformation to a control unit 108 that assesses if the breath hold valuemeets or exceeds a threshold value.

In some embodiments, operation 1010 includes assessing one or morevalues associated with one or more inhalation parameters and estimatinga quantity of the at least one active agent 214 that will be effectivelydelivered in response to the one or more assessed values associated withthe one or more inhalation parameters (not shown). In some embodiments,system 100 may be used to assess one or more values associated with oneor more inhalation parameters and estimate a quantity of at least oneactive agent 214 that will be effectively delivered in response to theone or more assessed values associated with the one or more inhalationparameters. Parameters associated with numerous inhalation parametersmay be assessed. Examples of such parameters include, but are notlimited to, volume of flow through one or more flow channels 104 duringan inhalation cycle by a subject using an inhaler, velocity of flowthrough one or more flow channels 104 during an inhalation cycle by asubject using an inhaler, frequency of inhalation by a subject using aninhaler, time of inhalation by a subject using an inhaler, quantity ofactive agent 214 flowing through one or more flow channels 104, and thelike. In some embodiments, a sensor 114 may be used to determine one ormore values associated with an inhalation parameter. The sensor 114 maythen transmit one or more signals that include the one or more values toa control unit 108 that uses the one or more values to estimate aquantity of at least one active agent 214 that will be delivered. Insome embodiments, a control unit 108 may utilize information that isrelated to a subject in combination with one or more assessed valuesassociated with an inhalation parameter. For example, in someembodiments, a control unit 108 may use the total volume of flow thatwas inhaled by a subject with an assessed inhalation value and aquantity of active agent 214 that flowed through a flow channel 104during an inhalation cycle to estimate a quantity of active agent 214that was effectively delivered to the subject.

In some embodiments, operation 1010 includes assessing one or morevalues associated with one or more breath hold parameters and estimatinga quantity of the at least one active agent 214 that will be effectivelydelivered in response to the one or more assessed values associated withthe one or more breath hold parameters (not shown). In some embodiments,system 100 may be used to assess one or more values associated with oneor more breath hold parameters and estimate a quantity of at least oneactive agent 214 that will be effectively delivered in response to theone or more assessed values associated with the one or more breath holdparameters. Parameters associated with numerous breath hold parametersmay be assessed. Examples of such parameters include, but are notlimited to, volume of flow held during a breath hold cycle, time periodof a breath hold cycle, quantity of active agent 214 flowing through oneor more flow channels 104 during inhalation prior to the breath holdcycle, and the like. In some embodiments, a sensor 114 may be used toassess one or more values associated with a breath hold cycle. Thesensor 114 may then transmit one or more signals that include the one ormore values to a control unit 108 that uses the one or more values toestimate a quantity of at least one active agent 214 that will bedelivered. In some embodiments, a control unit 108 may utilizeinformation that is related to a subject in combination with one or moreassessed values associated with a breath hold cycle. For example, insome embodiments, a control unit 108 may use a physical parameter, suchas total lung capacity, that is associated with a subject with adetermined breath hold value and a quantity of active agent 214 thatflowed through a flow channel 104 during an inhalation cycle to estimatea quantity of active agent 214 that was effectively delivered to thesubject.

In some embodiments, operation 1010 includes assessing one or morevalues associated with one or more inhalation parameters and estimatinga quantity of the at least one incentive agent 218 that will beeffectively delivered in response to the one or more assessed valuesassociated with the one or more inhalation parameters (not shown). Insome embodiments, system 100 may be used to assess one or more valuesassociated with one or more inhalation parameters and estimating aquantity of the at least one incentive agent 218 that will beeffectively delivered in response to the one or more assessed valuesassociated with the one or more inhalation parameters. Numerousinhalation parameters may be assessed. Examples of such parametersinclude, but are not limited to, volume of flow through one or more flowchannels 104 during an inhalation cycle, velocity of flow through one ormore flow channels 104 during an inhalation cycle, quantity of incentiveagent 218 flowing through one or more flow channels 104 during aninhalation cycle, and the like. In some embodiments, a sensor 114 may beused to assess one or more values associated with an inhalationparameter. The sensor 114 may then transmit one or more signals thatinclude the one or more values to a control unit 108 that uses the oneor more values to estimate a quantity of at least one incentive agent218 that will be delivered. In some embodiments, a control unit 108 mayutilize information that is related to a subject in combination with oneor more assessed values associated with an inhalation parameter. Forexample, in some embodiments, a control unit 108 may use a physicalparameter, such as total lung capacity, that is associated with asubject with an assessed value related to an inhalation parameter and aquantity of incentive agent 218 that flowed through a flow channel 104during an inhalation cycle to estimate a quantity of incentive agent 218that was effectively delivered to the subject.

In some embodiments, operation 1010 includes assessing one or morevalues associated with one or more breath hold parameters and estimatinga quantity of the at least one incentive agent 218 that will beeffectively delivered in response to the one or more assessed valuesassociated with the one or more breath hold parameters (not shown). Insome embodiments, system 100 may be used to assess one or more valuesassociated with one or more breath hold parameters and estimate aquantity of the at least one incentive agent 218 that will beeffectively delivered in response to the one or more assessed valuesassociated with the one or more breath hold parameters. Numerous breathhold parameters may be assessed. Examples of such parameters include,but are not limited to, volume of flow through one or more flow channels104 that is held during a breath hold cycle, a time period associatedwith a breath hold cycle, a quantity of incentive agent 218 flowingthrough one or more flow channels 104 during an inhalation cycle priorto the breath hold cycle, and the like. In some embodiments, a sensor114 may be used to assess one or more values associated with a breathhold parameter. The sensor 114 may then transmit one or more signalsthat include the one or more values to a control unit 108 that uses theone or more values to estimate a quantity of at least one incentiveagent 218 that will be delivered. In some embodiments, a control unit108 may utilize information that is related to a subject in combinationwith one or more assessed values associated with a breath holdparameter. For example, in some embodiments, a control unit 108 may usea physical parameter, such as total lung capacity, that is associatedwith a subject with an assessed value related to a breath hold parameterand a quantity of incentive agent 218 that flowed through a flow channel104 during an inhalation cycle to estimate a quantity of incentive agent218 that will be effectively delivered to the subject. In someembodiments, a control unit 108 may utilize an absorption rate that isassociated with an incentive agent 218 to estimate a quantity of theincentive agent 218 that will be delivered to a subject.

In some embodiments, operation 1020 includes administering the at leastone active agent 214 to the subject when at least one value associatedwith the one or more parameters associated with use of the inhaler meetsor exceeds a threshold value (not shown). In some embodiments, system100 may be used to administer at least one active agent 214 to a subjectwhen at least one value associated with one or more parametersassociated with use of an inhaler meets or exceeds a threshold value.For example, in some embodiments, a control unit 108 may receive one ormore signals that include one or more assessed values associated withvelocity of flow through one or more flow channels 104 disposed withinan inhaler during an inhalation cycle by a subject from a sensor 114.The control unit 108 may compare the one or more assessed values to oneor more threshold values associated with velocity of flow during aninhalation cycle and activate one or more actuators 120 to facilitate atleast partial release of one or more active agents 214 from one or moreactive agent reservoirs 212 to deliver the one or more active agents 214to the subject using the inhaler if the one or more assessed values meetor exceed the one or more threshold values.

In some embodiments, operation 1020 includes administering the at leastone active agent 214 to the subject in response to assessing at leastone value associated with a respiration parameter (not shown). In someembodiments, system 100 may be used to administer at least one activeagent 214 to the subject in response to assessing at least one valueassociated with a respiration parameter. For example, in someembodiments, a control unit 108 may receive one or more signals thatinclude one or more assessed values associated with a volume of flowthrough one or more flow channels 104 disposed within an inhaler used bya subject from a sensor 114. The control unit 108 may then utilize theassessed value to determine a quantity of active agent 214 to bereleased from an active agent reservoir 212 based on the assessed volumeof flow. In some embodiments, a control unit 108 may receive informationassociated with a time period associated with an inhalation cycle of asubject using an inhaler. The control unit 108 may then direct anactuator 120 to facilitate at least partial release from an active agentreservoir 212 during an early stage of an inhalation cycle.

In some embodiments, operation 1020 includes administering the at leastone active agent 214 to the subject when at least one value associatedwith a respiration parameter meets or exceeds a threshold value (notshown). In some embodiments, system 100 may be used to administer atleast one active agent 214 to a subject when at least one valueassociated with a respiration parameter meets or exceeds a thresholdvalue. For example, in some embodiments, a control unit 108 may receiveone or more signals that include one or more assessed values associatedwith velocity of flow through one or more flow channels 104 disposedwithin an inhaler used by a subject during an inhalation cycle from oneor more sensors 114. The control unit 108 may compare the one or moreassessed values to one or more threshold values associated with thevelocity of flow and activate one or more actuators 120 to facilitate atleast partial release of one or more active agents 214 from one or moreactive agent reservoirs 212 to administer the one or more active agents214 to the subject using the inhaler if the one or more assessed valuesassociated with velocity of flow meet or exceed the one or morethreshold values. In some embodiments, a control unit 108 may receiveone or more signals that include one or more assessed values associatedwith a volume of flow through one or more flow channels 104 disposedwithin an inhaler used by a subject during an exhalation cycle from asensor 114. The control unit 108 may compare the one or more assessedvalues to one or more threshold values associated with volume of flowduring an exhalation cycle. The control unit 108 may then receive one ormore signals that include one or more assessed values associated withvelocity of flow through one or more flow channels 104 disposed withinthe inhaler used by a subject during an inhalation cycle from a sensor114. The control unit 108 may then compare the one or more assessedvalues to one or more threshold values associated with velocity of flowduring an inhalation cycle. The control unit 108 may then activate oneor more actuators 120 to facilitate at least partial release of one ormore active agents 214 from one or more active agent reservoirs 212 toadminister the one or more formulations 214 to the subject using theinhaler if the one or more measured values associated with volume offlow and velocity of flow each meet or exceed threshold valuesassociated with the volume of flow and velocity of flow.

In some embodiments, operation 1020 includes administering the at leastone active agent 214 to the subject when at least one value associatedwith an inhalation parameter meets or exceeds a threshold value (notshown). In some embodiments, system 100 may be used to administer atleast one active agent 214 to a subject when at least one valueassociated with an inhalation parameter meets or exceeds a thresholdvalue. For example, in some embodiments, a control unit 108 may receiveone or more signals that include one or more assessed values associatedwith velocity of flow through one or more flow channels 104 disposedwithin an inhaler used by a subject during an inhalation cycle from asensor 114. The control unit 108 may compare the one or more assessedvalues to one or more threshold values associated with the velocity offlow and activate one or more actuators 120 to facilitate at leastpartial release of one or more active agents 214 from one or more activeagent reservoirs 212 to administer the one or more active agents 214 tothe subject using the inhaler if the one or more assessed valuesassociated with the velocity of flow during the inhalation cycle meet orexceed the one or more threshold values.

In some embodiments, operation 1020 includes administering the at leastone active agent 214 to the subject when at least one value associatedwith a breath hold parameter meets or exceeds a threshold value (notshown). In some embodiments, system 100 may be used to administer atleast one active agent 214 to a subject when at least one valueassociated with a breath hold parameter meets or exceeds a thresholdvalue. For example, in some embodiments, a control unit 108 may receiveone or more signals that include one or more assessed time valuesassociated with a breath hold period by a subject using an inhaler. Thecontrol unit 108 may compare the one or more assessed time values to oneor more threshold time values associated with a breath hold period andactivate one or more actuators 120 to facilitate at least partialrelease of one or more active agents 214 from one or more active agentreservoirs 212 to administer the one or more active agents 214 to thesubject using the inhaler if the one or more assessed time valuesassociated with the breath hold period meets or exceeds the one or morethreshold values. In some embodiments, a control unit 108 may receiveone or more signals that include one or more assessed values associatedwith a volume of flow held by a subject using an inhaler during a breathhold period from a sensor 114. The control unit 108 may compare the oneor more assessed values associated with the volume of flow held to oneor more threshold values associated with a volume of flow. The controlunit 108 may activate one or more actuators 120 to facilitate at leastpartial release of one or more active agents 214 from one or more activeagent reservoirs 212 to deliver the one or more active agents 214 to thesubject using the inhaler if the one or more assessed values associatedwith the volume of flow held by the subject during a breath hold cyclemeet or exceed the one or more threshold values.

In some embodiments, operation 1020 includes administering the at leastone active agent 214 to the subject when at least one value associatedwith an exhalation parameter meets or exceeds a threshold value (notshown). In some embodiments, system 100 may be used to administer atleast one active agent 214 to a subject when at least one valueassociated with an exhalation parameter meets or exceeds a thresholdvalue. For example, in some embodiments, a control unit 108 may receiveone or more signals that include one or more assessed values associatedwith a volume of flow through one or more flow channels 104 disposedwithin an inhaler used by a subject during an exhalation cycle from asensor 114. The control unit 108 may compare the one or more assessedvalues to one or more threshold values associated with the volume offlow and activate one or more actuators 120 to facilitate at leastpartial release of one or more active agents 214 from one or more activeagent reservoirs 212 to administer the one or more active agents 214 tothe subject using the inhaler if the one or more assessed valuesassociated with the volume of flow meet or exceed the one or morethreshold values. In some embodiments, a control unit 108 may activatean actuator 120 to facilitate at least partial release from one or moreactive agent reservoirs 212 at the beginning of an inhalation cycle thatfollows an exhalation cycle where the volume of flow that was exhaledmeets or exceeds a threshold value.

In some embodiments, operation 1020 includes administering the at leastone active agent 214 to the subject when at least one value associatedwith an exhalation parameter meets or exceeds a threshold value and whenat least one value associated with an inhalation parameter meets orexceeds a threshold value (not shown). In some embodiments, system 100may be used to administer at least one active agent 214 to a subjectwhen at least one value associated with an exhalation parameter meets orexceeds a threshold value and when at least one value associated with aninhalation parameter meets or exceeds a threshold value. For example, insome embodiments, a control unit 108 may receive one or more signalsthat include one or more assessed values associated with volume of flowthrough one or more flow channels 104 disposed within an inhaler used bya subject during an exhalation cycle from a sensor 114. The control unit108 may compare the one or more assessed values to one or more thresholdvalues associated with the volume of flow. The control unit 108 may thenreceive one or more signals that include one or more assessed valuesassociated with velocity of flow through one or more flow channels 104disposed within the inhaler used by the subject during an inhalationcycle and compare the one or more assessed values to one or morethreshold values associated with the velocity of flow. The control unit108 may then activate an actuator 120 to facilitate at least partialrelease from one or more active agent reservoirs 212 during theinhalation cycle if the velocity of flow during the inhalation cyclemeets or exceeds a threshold value and the volume of flow that wasexhaled meets or exceeds a threshold value.

In some embodiments, operation 1030 includes administering the at leastone incentive agent 218 after the at least one active agent 214 isadministered (not shown). In some embodiments, system 100 may be used toadminister at least one incentive agent 218 after at least one activeagent 214 is administered. In some embodiments, a control unit 108 maydirect one or more actuators 120 to facilitate at least partial releasefrom one or more active agent reservoirs 212 to administer one or moreactive agents 214 to a subject using an inhaler and then direct one ormore actuators 120 to facilitate at least partial release from one ormore incentive agent reservoirs 216 to administer one or more incentiveagents 218 to the subject.

In some embodiments, operation 1030 includes administering the at leastone incentive agent 218 substantially concurrently with the at least oneactive agent 214 (not shown). In some embodiments, system 100 may beused to administer the at least one incentive agent 218 substantiallyconcurrently with the at least one active agent 214. In someembodiments, a control unit 108 may direct one or more actuators 120 tofacilitate at least partial release from one or more active agentreservoirs 212 to administer one or more active agents 214 to a subjectusing an inhaler and direct one or more actuators 120 to facilitate atleast partial release from one or more incentive agent reservoirs 216 toadminister one or more incentive agents 218 to the subject atsubstantially the same time.

In some embodiments, operation 1030 includes administering the at leastone incentive agent 218 before the at least one active agent 214 isadministered (not shown). In some embodiments, system 100 may be used toadminister at least one incentive agent 218 before at least one activeagent 214 is administered. In some embodiments, a control unit 108 maydirect one or more actuators 120 to facilitate at least partial releasefrom one or more incentive agent reservoirs 216 to administer one ormore incentive agents 218 to a subject using an inhaler and then directone or more actuators 120 to facilitate at least partial release fromone or more active agent reservoirs 212 to administer one or more activeagents 214 to the subject at a later time.

In some embodiments, operation 1030 includes administering caffeine (notshown). In some embodiments, system 100 may be used to administercaffeine. In some embodiments, a control unit 108 may direct one or moreactuators 120 to facilitate at least partial release from one or moreincentive agent reservoirs 216 to administer caffeine to a subject usingan inhaler.

In some embodiments, operation 1030 includes administering nicotine (notshown). In some embodiments, system 100 may be used to administernicotine. In some embodiments, a control unit 108 may direct one or moreactuators 120 to facilitate at least partial release from one or moreincentive agent reservoirs 216 to administer nicotine to a subject usingan inhaler.

In some embodiments, operation 1030 includes administering a flavoringagent (not shown). In some embodiments, system 100 may be used toadminister a flavoring agent. In some embodiments, a control unit 108may direct one or more actuators 120 to facilitate at least partialrelease from one or more incentive agent reservoirs 216 to administer aflavoring agent to a subject using an inhaler. Numerous types offlavoring agents may be administered. Examples of flavoring agentsinclude, but are not limited to, orange flavoring agents, lemonflavoring agents, cherry flavoring agents, and the like.

In some embodiments, operation 1030 includes administering menthol (notshown). In some embodiments, system 100 may be used to administermenthol. In some embodiments, a control unit 108 may direct one or moreactuators 120 to facilitate at least partial release from one or moreincentive agent reservoirs 216 to administer menthol to a subject usingan inhaler.

In some embodiments, operation 1030 includes administering the at leastone incentive agent 218 in a quantity that is based on a quantity of theat least one active agent 214 that was delivered to the subject (notshown). In some embodiments, system 100 may be used to administer atleast one incentive agent 218 in a quantity that is based on a quantityof at least one active agent 214 that was delivered to a subject. Insome embodiments, an optical sensor 126 may be used to assess a quantityof one or more active agents 214 that flow through one or more flowchannels 104 disposed within an inhaler that is used by a subject. Insome embodiments, a phase Doppler interferometer 136 may be used toassess a quantity of one or more active agents 214 that flow through oneor more flow channels 104 disposed within an inhaler that is used by asubject. In some embodiments, an ultrasonic flow meter 140 may be usedto assess a quantity of one or more active agents 214 that flow throughone or more flow channels 104 disposed within an inhaler that is used bya subject. In some embodiments, a sensor 114 may transmit one or moresignals that include one or more assessed values associated with aquantity of one or more active agents 214 to a control unit 108 thatuses one or more assessed values to determine a quantity of one or moreactive agents 214 that were delivered to a subject using the inhaler.The control unit 108 may then direct one or more actuators 120 tofacilitate at least partial release from one or more incentive agentreservoirs 216 to administer one or more incentive agents 218 to asubject using the inhaler in a quantity that is related to the quantityof one or more active agents 214 that were administered to the subject.In some embodiments, the quantity of an incentive agent 218 may beproportional to the quantity of one or more active agents 214 that wereadministered to the subject.

In some embodiments, operation 1030 includes administering the at leastone incentive agent 218 in response to assessing the one or moreparameters associated with use of the inhaler (not shown). In someembodiments, system 100 may be used to administer at least one incentiveagent 218 in response to assessing one or more parameters associatedwith use of the inhaler. An incentive agent 218 may be administered inresponse to assessing numerous types of parameters. Examples of suchparameters include, but are not limited to, parameters associated withinhalation through an inhaler, parameters associated with exhalationthrough an inhaler, parameters associated with breath holding whileusing an inhaler, parameters associated with administration of one ormore active agents 214 to a subject using an inhaler, parametersassociated with administration of one or more incentive agents 218 to asubject using an inhaler, and the like. In some embodiments, a sensor114 may be configured to assess a quantity of one or more active agents214 that are administered to a subject through use of an inhaler. Thesensor 114 may transmit one or more signals that include the one or moreassessed values associated with the quantity of one or more activeagents 214 that are administered to a subject to a control unit 108. Thecontrol unit 108 may determine if the one or more assessed values meetor exceed a preselected dosage of the one or more active agents 214 thatare to be administered to the subject using the inhaler. If the one ormore values meet or exceed a preselected dosage the control unit 108 maydirect an actuator 120 to facilitate at least partial release from oneor more incentive agent reservoirs 216 to administer one or moreincentive agents 218 to the subject using the inhaler. In someembodiments, a sensor 114 may be configured to assess one or more valuesassociated with a quality of physical contact between the mouth of thesubject and the inhaler. The sensor 114 may transmit one or more signalsthat include the one or more assessed values associated with the qualityof physical contact to a control unit 108. The control unit 108 maydetermine if the one or more assessed values meet or exceed apreselected value. If the one or more values meet or exceed apreselected value the control unit 108 may direct an actuator 120 tofacilitate at least partial release from one or more incentive agentreservoirs 216 to administer one or more incentive agents 218 to thesubject using the inhaler.

In some embodiments, operation 1030 includes administering the at leastone incentive agent 218 in response to assessing at least one valueassociated with a respiration parameter associated with use of theinhaler (not shown). In some embodiments, system 100 may be used toadminister at least one incentive agent 218 in response to assessing atleast one value associated with a respiration parameter associated withuse of the inhaler. An incentive agent 218 may be administered inresponse to assessing numerous parameters related to respirationperformance by a subject. Examples of such parameters include, but arenot limited to, velocity of flow through one or more flow channelsdisposed within an inhaler during an inhalation cycle, velocity of flowthrough one or more flow channels disposed within an inhaler during anexhalation cycle, volume of flow through one or more flow channelsdisposed within an inhaler during an inhalation cycle, volume of flowthrough one or more flow channels disposed within an inhaler during anexhalation cycle, and the like. In some embodiments, an incentive agent218 may be administered to a subject using an inhaler in response to theperformance of the subject using the inhaler. For example, in someembodiments, a flow sensor 124 may measure the volume of flow throughone or more flow channels 104 disposed within an inhaler and transmitone or more signals that include the one or more assessed valuesassociated with the volume of flow to a control unit 108. The controlunit 108 may determine if the one or more assessed values associatedwith the volume of flow meet or exceed a threshold value associated witha volume of flow through the inhaler. If the one or more assessed valuesmeet or exceed a threshold value, the control unit 108 may direct anactuator 120 to facilitate at least partial release from one or moreincentive agent reservoirs 216 to administer one or more incentiveagents 218 to the subject using the inhaler.

In some embodiments, operation 1030 includes administering the at leastone incentive agent 218 in response to assessing at least one valueassociated with an inhalation parameter associated with use of theinhaler (not shown). In some embodiments, system 100 may be used toadminister at least one incentive agent 218 in response to assessing atleast one value associated with an inhalation parameter associated withuse of the inhaler. An incentive agent 218 may be administered inresponse to assessing numerous parameters related to inhalationperformance by a subject. Examples of such parameters include, but arenot limited to, velocity of flow through one or more flow channelsdisposed within an inhaler during an inhalation cycle, volume of flowthrough one or more flow channels disposed within an inhaler during aninhalation cycle, and the like. In some embodiments, a flow sensor 124may assess the volume of flow through one or more flow channels 104disposed within an inhaler during an inhalation cycle by a subject usingthe inhaler and transmit one or more signals that include the one ormore values associated with the assessed volume of flow to a controlunit 108. The control unit 108 may determine if the one or more assessedvalues associated with the measured volume of flow meet or exceed athreshold value associated with a volume of flow through the inhaler. Ifthe assessed flow meets or exceeds a threshold value, the control unit108 may direct an actuator to facilitate at least partial release fromone or more incentive agent reservoirs 216 to administer one or moreincentive agents 218 to the subject using the inhaler.

In some embodiments, operation 1030 includes administering the at leastone incentive agent 218 in response to assessing at least one valueassociated with a breath hold parameter associated with use of theinhaler (not shown). In some embodiments, system 100 may be used toadminister at least one incentive agent 218 in response to assessing atleast one value associated with a breath hold parameter associated withuse of the inhaler. An incentive agent 218 may be administered inresponse to assessing numerous parameters related to breath holdperformance by a subject using an inhaler. Examples of such parametersinclude, but are not limited to, volume of flow held during a breathhold cycle, length of a breath hold cycle, and the like. In someembodiments, a flow sensor 124 may assess the volume of flow that isheld during a breath hold cycle by a subject using the inhaler andtransmit one or more signals that include the one or more valuesassociated with the assessed volume of flow to a control unit 108. Thecontrol unit 108 may determine if the one or more values associated withthe assessed volume of flow meet or exceed a threshold value associatedwith a volume of flow through the inhaler. If the one or more assessedvalues meet or exceed a threshold value, the control unit 108 may directan actuator 120 to facilitate at least partial release from one or moreincentive agent reservoirs 216 to administer one or more incentiveagents 218 to the subject using the inhaler. In some embodiments, atimer 134 may assess the time of a breath hold cycle by a subject usingthe inhaler and transmit one or more signals that include the one ormore values associated with the assessed time to a control unit 108. Thecontrol unit 108 may determine if the one or more assessed valuesassociated with the time of the breath hold cycle meet or exceed athreshold value associated with the time. If the one or more assessedtime values meet or exceed a threshold value, the control unit 108 maydirect an actuator 120 to facilitate at least partial release from oneor more incentive agent reservoirs 216 to administer one or moreincentive agents 218 to the subject using the inhaler.

In some embodiments, operation 1030 includes administering the at leastone incentive agent 218 in response to assessing at least one valueassociated with an exhalation parameter associated with use of theinhaler (not shown). In some embodiments, system 100 may be used toadminister at least one incentive agent 218 in response to assessing atleast one value associated with an exhalation parameter associated withuse of the inhaler. An incentive agent 218 may be administered inresponse to assessing numerous parameters related to exhalationperformance by a subject. Examples of such parameters include, but arenot limited to, velocity of flow through one or more flow channels 104disposed within an inhaler during an exhalation cycle, volume of flowthrough one or more flow channels 104 disposed within an inhaler duringan exhalation cycle, and the like. In some embodiments, a flow sensor124 may assess the volume of flow through one or more flow channels 104disposed within an inhaler during an exhalation cycle by a subject usingthe inhaler and transmit one or more signals that include one or morevalues associated with the assessed volume of flow to a control unit108. The control unit 108 may determine if the one or more assessedvalues associated with the volume of flow meet or exceed a thresholdvalue associated with a volume of flow through the inhaler. If theassessed flow meets or exceeds a threshold value, the control unit 108may direct an actuator 120 to facilitate at least partial release fromone or more incentive agent reservoirs 216 to administer one or moreincentive agents 218 to the subject using the inhaler.

In some embodiments, operation 1030 includes administering the at leastone incentive agent 218 to the subject when at least one valueassociated with the one or more parameters associated with use of theinhaler meets or exceeds a threshold value (not shown). In someembodiments, system 100 may be used to administer at least one incentiveagent 218 to the subject when at least one value associated with one ormore parameters associated with use of the inhaler meets or exceeds athreshold value. Numerous parameters associated with use of an inhalermay be assessed. In some embodiments, such parameters may include, butare not limited to, velocity of flow through one or more flow channels104 disposed within an inhaler during an inhalation cycle, a breath holdcycle, or an exhalation cycle. In some embodiments, such parameters mayinclude, but are not limited to, volume of flow through one or more flowchannels 104 disposed within an inhaler during an inhalation cycle, abreath hold cycle, or an exhalation cycle. In some embodiments, suchparameters may be associated with the quality of physical contactbetween the mouth of the subject and the inhaler. Accordingly, in someembodiments, a sensor 114 may assess one or more values associated withone or more parameters associated with use of an inhaler. The sensor 114may transmit one or more signals that include the one or more assessedvalues to a control unit 108 that determines if the one or more assessedvalues meet or exceed one or more threshold values associated with theone or more parameters. If the one or more assessed values meet orexceed one or more threshold values, the control unit 108 may direct anactuator 120 to facilitate at least partial release from one or moreincentive agent reservoirs 216 to administer one or more incentiveagents 218 to the subject using the inhaler.

In some embodiments, operation 1030 includes administering the at leastone incentive agent to the subject when at least one value associatedwith a respiration parameter meets or exceeds a threshold value (notshown). In some embodiments, system 100 may be used to administer atleast one incentive agent to a subject when at least one valueassociated with a respiration parameter meets or exceeds a thresholdvalue. Numerous respiration parameters may be assessed. In someembodiments, such parameters may include, but are not limited to,velocity of flow through one or more flow channels 104 disposed withinan inhaler during an inhalation cycle, a breath hold cycle, or anexhalation cycle. In some embodiments, such parameters may include, butare not limited to, volume of flow through one or more flow channels 104disposed within an inhaler during an inhalation cycle, a breath holdcycle, or an exhalation cycle. Accordingly, in some embodiments, asensor 114 may assess one or more values associated with one or morerespiration parameters and transmit one or more signals that include theone or more assessed values to a control unit 108. The control unit 108may determine if the one or more assessed values meet or exceed one ormore threshold values associated with the one or more respirationparameters. If the one or more assessed values meet or exceed one ormore threshold values, the control unit 108 may direct an actuator 120to facilitate at least partial release from one or more incentive agentreservoirs 216 to administer one or more incentive agents 218 to thesubject using the inhaler.

In some embodiments, operation 1030 includes administering the at leastone incentive agent to the subject when at least one value associatedwith an inhalation parameter meets or exceeds a threshold value (notshown). In some embodiments, system 100 may be used to administer atleast one incentive agent to a subject when at least one valueassociated with an inhalation parameter meets or exceeds a thresholdvalue. Numerous inhalation parameters may be assessed. In someembodiments, such inhalation parameters may include, but are not limitedto, velocity of flow through one or more flow channels 104 disposedwithin an inhaler during an inhalation cycle, volume of flow through oneor more flow channels 104 disposed within an inhaler during aninhalation cycle, a period of time associated with an inhalation cycle,a quantity of active agent 214 released from an active agent reservoir212 during an inhalation cycle, and the like. Accordingly, in someembodiments, a sensor 114 may assess one or more values associated withone or more inhalation parameters and transmit one or more signals thatinclude the one or more assessed values to a control unit 108. Thecontrol unit 108 may determine if the one or more assessed values meetor exceed one or more threshold values associated with the one or moreinhalation parameters. If the one or more assessed values meet or exceedone or more threshold values, the control unit 108 may direct anactuator 120 to facilitate at least partial release from one or moreincentive agent reservoirs 216 to administer one or more incentiveagents 218 to the subject using the inhaler.

In some embodiments, operation 1030 includes administering the at leastone incentive agent to the subject when at least one value associatedwith a breath hold parameter meets or exceeds a threshold value (notshown). In some embodiments, system 100 may be used to administer atleast one incentive agent to a subject when at least one valueassociated with a breath hold parameter meets or exceeds a thresholdvalue. Numerous breath hold parameters may be assessed. In someembodiments, such breath hold parameters may include, but are notlimited to, a volume of flow held during a breath hold cycle, a timeperiod associated with a breath hold cycle, a quantity of active agent214 administered to a subject during an inhalation cycle preceding abreath hold cycle, and the like. Accordingly, in some embodiments, asensor 114 may assess one or more values associated with one or morebreath hold parameters and transmit one or more signals that include theone or more assessed values to a control unit 108. The control unit 108may determine if the one or more assessed values meet or exceed one ormore threshold values associated with the one or more breath holdparameters. If the one or more assessed values meet or exceed one ormore threshold values, the control unit 108 may direct an actuator 120to facilitate at least partial release from one or more incentive agentreservoirs 216 to administer one or more incentive agents 218 to thesubject using the inhaler.

In some embodiments, operation 1030 includes administering the at leastone incentive agent to the subject when at least one value associatedwith an exhalation parameter meets or exceeds a threshold value (notshown). In some embodiments, system 100 may be used to administer atleast one incentive agent to a subject when at least one valueassociated with an exhalation parameter meets or exceeds a thresholdvalue. Numerous exhalation parameters may be assessed. In someembodiments, such exhalation parameters may include, but are not limitedto, a volume of flow through one or more flow channels disposed withinan inhaler during an exhalation cycle, a time period associated with anexhalation cycle, and the like. Accordingly, in some embodiments, asensor 114 may assess one or more values associated with one or moreexhalation parameters and transmit one or more signals that include theone or more assessed values to a control unit 108. The control unit 108may determine if the one or more assessed values meet or exceed one ormore threshold values associated with the one or more exhalationparameters. If the one or more assessed values meet or exceed one ormore threshold values, the control unit 108 may direct an actuator 120to facilitate at least partial release from one or more incentive agentreservoirs 216 to administer one or more incentive agents 218 to thesubject using the inhaler.

In some embodiments, operation 1030 includes administering the at leastone incentive agent to the subject when at least one value associatedwith an exhalation parameter meets or exceeds a threshold value and whenat least one value associated with an inhalation parameter meets orexceeds a threshold value (not shown). In some embodiments, system 100may be used to administer at least one incentive agent to a subject whenat least one value associated with an exhalation parameter meets orexceeds a threshold value and when at least one value associated with aninhalation parameter meets or exceeds a threshold value. Numerousexhalation parameters may be assessed. Examples of such exhalationparameters include, but are not limited to, velocity of flow through oneor more flow channels disposed within an inhaler during an exhalationcycle by a subject using the inhaler, volume of flow through one or moreflow channels disposed within an inhaler during an exhalation cycle by asubject using the inhaler, a period of time associated with anexhalation cycle by a subject using the inhaler, and the like. Numerousinhalation parameters may be assessed. Examples of such inhalationparameters include, but are not limited to, velocity of flow through oneor more flow channels disposed within an inhaler during an inhalationcycle by a subject using the inhaler, volume of flow through one or moreflow channels disposed within an inhaler during an inhalation cycle by asubject using the inhaler, a period of time associated with aninhalation cycle by a subject using the inhaler, and the like.Accordingly, in some embodiments, a sensor 114 may assess one or morevalues associated with one or more exhalation parameters and transmitone or more signals that include the one or more assessed values to acontrol unit 108. The control unit 108 may determine if the one or moreassessed values meet or exceed one or more threshold values associatedwith the one or more exhalation parameters. A sensor 114 may assess oneor more values associated with one or more inhalation parameters andtransmit one or more signals that include the one or more assessedvalues to a control unit 108. The control unit 108 may determine if theone or more assessed values meet or exceed one or more threshold valuesassociated with the one or more inhalation parameters. If the one ormore assessed values associated with the one or more exhalationparameters and the one or more inhalation parameters meet or exceed oneor more threshold values, the control unit 108 may direct an actuator120 to facilitate at least partial release from one or more incentiveagent reservoirs 216 to administer one or more incentive agents 218 tothe subject using the inhaler.

FIG. 11 illustrates operational flow 1100 that includes operation 1110that includes assessing one or more parameters associated with use of aninhaler by a subject, operation 1120 that includes administering atleast one active agent 214 to the subject in response to assessing theone or more parameters associated with use of the inhaler, operation1130 that includes administering at least one incentive agent 218 to thesubject in coordination with administering the at least one active agent214, and operation 1140 that includes displaying a comparison of anassessed value associated with one or more respiration parameters withone or more levels associated with the one or more respirationparameters. Operations 1110, 1120, and 1130 correspond to operations1010, 1020, and 1030 as previously described with reference to FIG. 10.

In FIG. 11 and in the following description that includes variousexamples of operations used during performance of the method, discussionand explanation may be provided with respect to any one or combinationof the above-described examples, and/or with respect to other examplesand contexts. However, it should be understood that the operations maybe executed in a number of other environments and contexts, and/ormodified versions of the figures. Also, although the various operationsare presented in the sequence(s) illustrated, it should be understoodthat the various operations may be performed in other orders than thosewhich are illustrated, or may be performed concurrently.

Operation 1140 includes displaying a comparison of an assessed valueassociated with one or more respiration parameters with one or morelevels associated with the one or more respiration parameters. In someembodiments, system 100 may display a comparison of an assessed valueassociated with one or more respiration parameters with one or morelevels associated with the one or more respiration parameters. In someembodiments, one or more performance indicators 116 may display acomparison of an assessed value associated with one or more respirationparameters with one or more levels associated with the one or morerespiration parameters. A performance indicator 116 may display acomparison of numerous assessed values to numerous levels associatedwith one or more respiration parameters. A performance indicator 116 maydisplay a comparison in numerous formats. For example, in someembodiments, a performance indicator 116 may display a comparison in anumeric format. In some embodiments, a performance indicator 116 maydisplay a comparison in a colorimetric format. In some embodiments, aperformance indicator 116 may display a comparison in an audio format.Examples of respiration parameters include, but are not limited to,volume of flow through one or more flow channels 104 disposed within aninhaler, velocity of flow through one or more flow channels 104 disposedwithin an inhaler, a time period associated with flow through one ormore flow channels 104 disposed within an inhaler, and the like. In someembodiments, a performance indicator 116 may display the quality ofphysical contact between the mouth of a subject and a mouthpiece 268associated with an inhaler. In some embodiments, a flow sensor 124 maybe used to assess a value associated with flow through one or more flowchannels 104 disposed within an inhaler used by a subject during aninhalation cycle. The flow sensor 124 may transmit one or more signals112 that include the assessed value to a performance indicator 116 thatdisplays a comparison of the assessed value with one or more levelsassociated with flow through the one or more flow channels 104 during aninhalation cycle. In some embodiments, the flow sensor 124 may transmitone or more signals 112 that include an assessed value associated withflow through one or more flow channels 104 to a control unit 108 thatprocesses the information and then transmits one or more signals 112 toa performance indicator 116 that displays a comparison of the assessedvalue with one or more levels associated with flow through the one ormore flow channels 104. In some embodiments, such levels associated withone or more respiration parameters may be threshold levels. For example,in some embodiments, such levels may represent either or both of anupper and lower flow level that are associated with a desired level offlow though one or more flow channels 104 disposed within an inhaler.

In some embodiments, operation 1140 includes displaying a comparison ofthe assessed value associated with one or more respiration parameters toa range of levels associated with the one or more respiration parametersand instructing the subject to achieve a value of the one or morerespiration parameters that is within a range of threshold levelsassociated with the one or more respiration parameters (not shown). Insome embodiments, system 100 may be used to display a comparison of anassessed value associated with one or more respiration parameters to arange of levels associated with the one or more respiration parametersand instruct a subject to achieve a value of the one or more respirationparameters that is within a range of threshold levels associated withthe one or more respiration parameters. Values related to numerousrespiration parameters may be assessed and compared to ranges associatedwith the respiration parameters. Examples of such respiration parametersinclude, but are not limited to, velocity of flow through one or moreflow channels 104 disposed within an inhaler, volume of flow through oneor more flow channels 104 disposed within an inhaler, time of flowthrough one or more flow channels 104 disposed within an inhaler, amountof active agent 214 flowing through one or more flow channels 104disposed within an inhaler, amount of incentive agent 218 flowingthrough one or more flow channels 104 disposed within an inhaler, andthe like. For example, in some embodiments, a flow sensor 124 may beused to assess one or more values associated with volume of flow throughone or more flow channels 104 disposed within an inhaler when theinhaler is used by a subject. The flow sensor 124 may transmit one ormore signals 112 that include the one or more assessed values to aperformance indicator 116 which displays the one or more assessed valuesin comparison to a range of levels associated with one or moreparameters associated with a volume of flow. In some embodiments, avelocimeter 138 may be configured to determine one or more valuesassociated with the velocity of flow during an inhalation cycle and anexhalation cycle through one or more flow channels 104 disposed withinan inhaler used by a subject. The velocimeter 138 may transmit one ormore signals 112 that include the one or more assessed values to aperformance indicator 116 that displays the one or more assessed valuesin comparison to one or more ranges of levels associated with thevelocity of flow. In some embodiments, a performance indicator 116 mayinstruct a subject to achieve one or more values associated with one ormore respiration parameters that is within the range of levelsassociated with the one or more respiration parameters. For example, insome embodiments, a performance indicator 116 may instruct a subject toincrease volume of flow through one or more flow channels 104 disposedwithin an inhaler. In some embodiments, a performance indicator 116 mayinstruct a subject to decrease volume of flow through one or more flowchannels 104 disposed within an inhaler. In some embodiments, aperformance indicator 116 may instruct a subject to maintain theircurrent level of flow through one or more flow channels 104 disposedwithin an inhaler. In some embodiments, a performance indicator 116 mayinstruct a subject to increase volume of flow during an exhalation cyclethrough one or more flow channels 104 disposed within an inhaler. Insome embodiments, a performance indicator 116 may instruct a subject todecrease volume of flow during an exhalation cycle through one or moreflow channels 104 disposed within an inhaler. In some embodiments, aperformance indicator 116 may instruct a subject to maintain theircurrent level of flow during an exhalation cycle through one or moreflow channels 104 disposed within an inhaler. In some embodiments, aperformance indicator 116 may instruct a subject to increase the lengthof a breath hold cycle while using an inhaler. In some embodiments, aperformance indicator 116 may instruct a subject to decrease the lengthof a breath hold cycle while using an inhaler. In some embodiments, aperformance indicator 116 may instruct a subject to maintain theircurrent length of a breath hold cycle while using an inhaler.Accordingly, in some embodiments, a performance indicator 116 may beused to instruct a subject with regard to numerous respirationparameters. In some embodiments, a control unit 108 may be operablycoupled with one or more sensors 114 that are configured to assess oneor more values associated with one or more respiration parameters. Thecontrol unit 108 may receive one or more signals 112 that include theone or more assessed values related to one or more respirationparameters from the one or more sensors 114 and then direct one or moreperformance indicators 116 to display a comparison of the one or moreassessed values to one or more ranges of levels associated with the oneor more respiration parameters. In some embodiments, a control unit 108may receive one or more signals 112 that include one or more assessedvalues related to one or more respiration parameters from one or moresensors 114 and then direct one or more performance indicators 116 toinstruct a subject to achieve a value of the one or more respirationparameters that is within the range of levels associated with the one ormore respiration parameters.

In some embodiments, operation 1140 includes displaying a comparison ofthe assessed value associated with one or more inhalation parameters toa range of levels associated with the one or more inhalation parametersand instructing the subject to achieve a value of the one or moreinhalation parameters that is within a range of threshold levelsassociated with the one or more inhalation parameters (not shown). Insome embodiments, system 100 may be used to display a comparison of anassessed value associated with one or more inhalation parameters to arange of levels associated with the one or more inhalation parametersand instruct a subject to achieve a value of the one or more inhalationparameters that is within a range of threshold levels associated withthe one or more inhalation parameters. Values related to numerousinhalation parameters may be assessed and compared to ranges of levelsassociated with the inhalation parameters. Examples of such inhalationparameters include, but are not limited to, velocity of flow through oneor more flow channels 104 disposed within an inhaler during aninhalation cycle, volume of flow through one or more flow channels 104disposed within an inhaler during an inhalation cycle, time of flowthrough one or more flow channels 104 disposed within an inhaler duringan inhalation cycle, amount of active agent 214 flowing through one ormore flow channels 104 disposed within an inhaler during an inhalationcycle, amount of incentive agent 218 flowing through one or more flowchannels 104 disposed within an inhaler during an inhalation cycle, andthe like. For example, in some embodiments, a flow sensor 124 may beused to assess one or more values associated with volume of flow throughone or more flow channels 104 disposed within an inhaler during aninhalation cycle. The flow sensor 124 may transmit one or more signals112 that include the one or more assessed values to a performanceindicator 116 which displays a comparison of the one or more assessedvalues to a range of levels associated with one or more inhalationparameters. In some embodiments, a velocimeter 138 may be used to assessone or more values associated with the velocity of flow through one ormore flow channels 104 disposed within an inhaler during an inhalationcycle. The velocimeter 138 may transmit one or more signals 112 thatinclude the one or more assessed values to a performance indicator 116that displays the one or more assessed values in comparison to one ormore ranges of levels associated with the one or more inhalationparameters. The performance indicator 116 may display the comparison innumerous formats. In some embodiments, a performance indicator 116 mayinstruct a subject to achieve one or more values associated with one ormore inhalation parameters that is within the range of levels associatedwith the one or more inhalation parameters. For example, in someembodiments, a performance indicator 116 may instruct a subject toincrease the velocity of flow through an inhaler. In some embodiments, aperformance indicator 116 may instruct a subject to decrease thevelocity of flow through an inhaler. In some embodiments, a performanceindicator 116 may instruct a subject to maintain a velocity of flowthrough an inhaler. In some embodiments, a performance indicator 116 mayinstruct a subject using an inhaler to increase the time period of aninhalation cycle through an inhaler. In some embodiments, a performanceindicator 116 may instruct a subject to decrease the time period of aninhalation cycle through an inhaler. In some embodiments, a performanceindicator 116 may instruct a subject to maintain the time period of aninhalation cycle through an inhaler. Accordingly, in some embodiments, aperformance indicator 116 may be used to instruct a subject with regardto numerous inhalation parameters. In some embodiments, a control unit108 may be operably coupled with one or more sensors 114 that areconfigured to assess on or more values associated with one or moreinhalation parameters. The control unit 108 may receive one or moresignals 112 that include assessed values related to one or moreinhalation parameters from the one or more sensors 114 and then directone or more performance indicators 116 to display a comparison of theone or more assessed values to one or more ranges of levels associatedwith the one or more inhalation parameters. In some embodiments, acontrol unit 108 may receive one or more signals that include assessedvalues related to one or more inhalation parameters from the one or moresensors 114 and then direct one or more performance indicators 116 toinstruct the subject to achieve a value of the one or more inhalationparameters that is within the range of levels associated with the one ormore inhalation parameters.

In some embodiments, operation 1140 includes displaying a comparison ofthe assessed value associated with one or more breath hold parameters toa range of levels associated with the one or more breath hold parametersand instructing the subject to achieve a value of the one or more breathhold parameters that is within the range of threshold levels associatedwith the one or more breath hold parameters (not shown). In someembodiments, system 100 may be used to display a comparison of anassessed value associated with one or more breath hold parameters to arange of levels associated with the one or more breath hold parametersand instruct a subject to achieve a value of the one or more breath holdparameters that is within the range of threshold levels associated withthe one or more breath hold parameters. Values related to numerousbreath hold parameters may be assessed and compared to ranges of levelsassociated with the breath hold parameters. Examples of such breath holdparameters include, but are not limited to, a time period associatedwith a breath hold cycle, an inhaled volume associated with a breathhold cycle, a quantity of active agent 214 that is inhaled and heldduring a breath hold cycle, a quantity of an incentive agent 218 that isinhaled and held during a breath hold cycle, and the like. For example,in some embodiments, a flow sensor 124 may be used to assess one or morevalues associated with a volume of flow that is held during a breathhold cycle. In some embodiments, a timer 134 may be used to assess oneor more values associated with a time period associated with a breathhold cycle. In some embodiments, a sensor 114 may transmit one or moresignals 112 that include one or more assessed values to a performanceindicator 116 which displays the one or more assessed values incomparison to a range of levels associated with one or more breath holdparameters. The performance indicator 116 may display the comparison innumerous formats. In some embodiments, a performance indicator 116 mayinstruct a subject to achieve one or more values associated with one ormore breath hold parameters that are within a range of levels associatedwith the one or more breath hold parameters. For example, in someembodiments, a performance indicator 116 may instruct a subject toincrease the volume of flow that is held during a breath hold cycle. Insome embodiments, a performance indicator 116 may instruct a subject todecrease the volume of flow that is held during a breath hold cycle. Insome embodiments, a performance indicator 116 may instruct a subject toincrease the time period of a breath hold cycle. In some embodiments, aperformance indicator 116 may instruct a subject to decrease the timeperiod of a breath hold cycle. Accordingly, in some embodiments, aperformance indicator 116 may be used to instruct a subject with regardto numerous breath hold parameters. In some embodiments, a control unit108 may be operably coupled with one or more sensors 114 that areconfigured to assess on or more values associated with one or morebreath hold parameters. The control unit 108 may receive one or moresignals 112 that include assessed values related to one or more breathhold parameters from the one or more sensors 114 and then direct one ormore performance indicators 116 to display a comparison of the one ormore assessed values to one or more ranges of levels associated with theone or more breath hold parameters. In some embodiments, a control unit108 may receive one or more signals 112 that include one or moreassessed values related to one or more breath hold parameters from oneor more sensors 114 and then direct one or more performance indicators116 to instruct a subject to achieve a value of the one or more breathhold parameters that is within the range of levels associated with theone or more breath hold parameters.

In some embodiments, operation 1140 includes displaying a comparison ofan assessed value associated with one or more exhalation parameters to arange of levels associated with the one or more exhalation parametersand instructing the subject to achieve a value of the one or moreexhalation parameters that is within the range of threshold levelsassociated with the one or more exhalation parameters (not shown). Insome embodiments, system 100 may be used to display a comparison of anassessed value associated with one or more exhalation parameters to arange of levels associated with the one or more exhalation parametersand instruct a subject to achieve a value of the one or more exhalationparameters that is within the range of threshold levels associated withthe one or more exhalation parameters. Values related to numerousexhalation parameters may be assessed and compared to ranges of levelsassociated with the exhalation parameters. Examples of such exhalationparameters include, but are not limited to, velocity of flow through oneor more flow channels 104 disposed within an inhaler during anexhalation cycle, volume of flow through one or more flow channels 104disposed within an inhaler during an exhalation cycle, time of flowthrough one or more flow channels 104 disposed within an inhaler duringan exhalation cycle, amount of active agent 214 flowing through one ormore flow channels 104 disposed within an inhaler during an exhalationcycle, amount of incentive agent 218 flowing through one or more flowchannels 104 disposed within an inhaler during an exhalation cycle, andthe like. For example, in some embodiments, a flow sensor 124 may beused to assess one or more values associated with volume of flow throughone or more flow channels 104 disposed within an inhaler during anexhalation cycle. The flow sensor 124 may transmit one or more signals112 that include the one or more assessed values to a performanceindicator 116 which displays a comparison of the one or more assessedvalues to a range of levels associated with one or more exhalationparameters. In some embodiments, a velocimeter 138 may be used to assessone or more values associated with the velocity of flow through one ormore flow channels 104 disposed within an inhaler during an exhalationcycle. The velocimeter 138 may transmit one or more signals 112 thatinclude the one or more assessed values to a performance indicator 116that displays the one or more assessed values in comparison to one ormore ranges of levels associated with the one or more exhalationparameters. The performance indicator 116 may display the comparison innumerous formats. In some embodiments, a performance indicator 116 mayinstruct a subject to achieve one or more values associated with one ormore exhalation parameters that is within the range of levels associatedwith the one or more exhalation parameters. For example, in someembodiments, a performance indicator 116 may instruct a subject toincrease the velocity of flow through an inhaler. In some embodiments, aperformance indicator 116 may instruct a subject to decrease thevelocity of flow through an inhaler. In some embodiments, a performanceindicator 116 may instruct a subject to maintain a velocity of flowthrough an inhaler. In some embodiments, a performance indicator 116 mayinstruct a subject using an inhaler to increase the time period of anexhalation cycle through an inhaler. In some embodiments, a performanceindicator 116 may instruct a subject to decrease the time period of anexhalation cycle through an inhaler. In some embodiments, a performanceindicator 116 may instruct a subject to maintain the time period of anexhalation cycle through an inhaler. Accordingly, in some embodiments, aperformance indicator 116 may be used to instruct a subject with regardto numerous exhalation parameters. In some embodiments, a control unit108 may be operably coupled with one or more sensors 114 that areconfigured to assess on or more values associated with one or moreexhalation parameters. The control unit 108 may receive one or moresignals 112 that include an assessed value related to one or moreexhalation parameters from the one or more sensors 114 and then directone or more performance indicators 116 to display a comparison of theone or more assessed values to one or more ranges of levels associatedwith the one or more exhalation parameters. In some embodiments, acontrol unit 108 may receive one or more signals that include anassessed value related to one or more exhalation parameters from the oneor more sensors 114 and then direct one or more performance indicators116 to instruct the subject to achieve a value of the one or moreexhalation parameters that is within the range of levels associated withthe one or more exhalation parameters.

In some embodiments, operation 1140 includes displaying a comparison ofan assessed value associated with one or more exhalation parameters to arange of levels associated with the one or more exhalation parametersand instructing the subject to achieve a value of the one or moreexhalation parameters that is within the range of threshold levelsassociated with the one or more exhalation parameters and thendisplaying a comparison of an assessed value associated with one or moreinhalation parameters to a range of levels associated with the one ormore inhalation parameters and instructing the subject to achieve avalue of the one or more inhalation parameters that is within the rangeof threshold levels associated with the one or more inhalationparameters (not shown). In some embodiments, system 100 may be used todisplay a comparison of an assessed value associated with one or moreexhalation parameters to a range of levels associated with the one ormore exhalation parameters and instruct a subject to achieve a value ofthe one or more exhalation parameters that is within the range ofthreshold levels associated with the one or more exhalation parametersand then display a comparison of an assessed value associated with oneor more inhalation parameters to a range of levels associated with theone or more inhalation parameters and instruct the subject to achieve avalue of the one or more inhalation parameters that is within the rangeof threshold levels associated with the one or more inhalationparameters. In some embodiments, a performance indicator 116 may displaya comparison of one or more assessed exhalation parameters to a range oflevels associated with the one or more exhalation parameters. Forexample, in some embodiments, a performance indicator 116 may receiveone or more signals 112 that include one or more assessed valuesassociated with one or more exhalation parameters from one or moresensors 114 and display the one or more values in comparison to a rangeof levels associated with the one or more exhalation parameters. In someembodiments, a control unit 108 may receive one or more signals 112 thatinclude one or more assessed values that are associated with one or moreexhalation parameters from one or more sensors 114 and then direct aperformance indicator 116 to display the one or more values associatedwith one or more exhalation parameters in comparison to one or morelevels associated with the one or more exhalation parameters. In someembodiments, a performance indicator 116 may instruct a subject toachieve a value of one or more exhalation parameters that are within arange of levels associated with the one or more exhalation parameters.In some embodiments, a control unit 108 may direct a performanceindicator 116 to instruct a subject to achieve a value of one or moreexhalation parameters that are within a range of levels associated withthe one or more exhalation parameters. In some embodiments, aperformance indicator 116 may display a comparison of one or moreassessed inhalation parameters to a range of levels associated with theone or more inhalation parameters. For example, in some embodiments, aperformance indicator 116 may receive one or more signals 112 thatinclude one or more assessed values that are associated with one or moreinhalation parameters from one or more sensors 114 and display the oneor more values in comparison to a range of levels associated with theone or more inhalation parameters. In some embodiments, a control unit108 may receive one or more signals 112 that include one or moreassessed values associated with one or more inhalation parameters fromone or more sensors 114 and then direct a performance indicator 116 todisplay the one or more values associated with one or more inhalationparameters in comparison to one or more levels associated with the oneor more inhalation parameters. In some embodiments, a performanceindicator 116 may instruct a subject to achieve a value of one or moreinhalation parameters that are within a range of levels associated withthe one or more inhalation parameters. In some embodiments, a controlunit 108 may direct a performance indicator 116 to instruct a subject toachieve a value of one or more inhalation parameters that are within arange of levels associated with the one or more inhalation parameters.

FIG. 12 illustrates operational flow 1200 that includes operation 1210that includes assessing one or more parameters associated with use of aninhaler by a subject, operation 1220 that includes administering atleast one active agent 214 to the subject in response to assessing theone or more parameters associated with use of the inhaler, operation1230 that includes administering at least one incentive agent 218 to thesubject in coordination with administering the at least one active agent214, and operation 1240 that includes instructing the subject to achieveone or more values associated with one or more respiration parameters.Operations 1210, 1220, and 1230 correspond to operations 1010, 1020, and1030 as previously described with reference to FIG. 10.

In FIG. 12 and in the following description that includes variousexamples of operations used during performance of the method, discussionand explanation may be provided with respect to any one or combinationof the above-described examples, and/or with respect to other examplesand contexts. However, it should be understood that the operations maybe executed in a number of other environments and contexts, and/ormodified versions of the figures. Also, although the various operationsare presented in the sequence(s) illustrated, it should be understoodthat the various operations may be performed in other orders than thosewhich are illustrated, or may be performed concurrently.

Operation 1240 includes instructing the subject to achieve one or morevalues associated with one or more respiration parameters. In someembodiments, system 100 may be used to instruct a subject to achieve oneor more values associated with one or more respiration parameters. Insome embodiments, a performance indicator 116 may instruct a subject toachieve one or more values associated with one or more respirationparameters. A performance indicator may instruct a subject to achieveone or more values associated with numerous types of respirationparameters. Examples of such respiration parameters include, but are notlimited to, parameters associated with flow through one or more flowchannels 104 disposed within an inhaler, release of one or more activeagents 214 from one or more active agent reservoirs 212, release of oneor more incentive agents 218 from one or more incentive agent reservoirs216, and the like. For example, in some embodiments, a performanceindicator 116 may instruct a subject to increase volume of flow throughone or more flow channels 104 disposed within an inhaler. In someembodiments, a performance indicator 116 may instruct a subject todecrease volume of flow through one or more flow channels 104 disposedwithin an inhaler. In some embodiments, a performance indicator 116 mayinstruct a subject to maintain their current level of flow through oneor more flow channels 104 disposed within an inhaler. In someembodiments, a performance indicator 116 may instruct a subject toincrease volume of flow during an exhalation cycle through one or moreflow channels 104 disposed within an inhaler. In some embodiments, aperformance indicator 116 may instruct a subject to decrease volume offlow during an exhalation cycle through one or more flow channels 104disposed within an inhaler. In some embodiments, a performance indicator116 may instruct a subject to maintain their current level of flowduring an exhalation cycle through one or more flow channels 104disposed within an inhaler. In some embodiments, a performance indicator116 may instruct a subject to increase the length of a breath hold cyclewhile using an inhaler. In some embodiments, a performance indicator 116may instruct a subject to decrease the length of a breath hold cyclewhile using an inhaler. In some embodiments, a performance indicator 116may instruct a subject to maintain their current length of a breath holdcycle while using an inhaler. Accordingly, in some embodiments, aperformance indicator 116 may be used to instruct a subject with regardto numerous respiration parameters. In some embodiments, a control unit108 may be operably coupled with one or more sensors 114 that areconfigured to assess one or more values associated with one or morerespiration parameters. In some embodiments, a control unit 108 mayreceive one or more signals 112 that include one or more assessed valuesrelated to one or more respiration parameters from one or more sensors114 and then direct one or more performance indicators 116 to instruct asubject to achieve a value assigned to the one or more respirationparameters.

In some embodiments, operation 1240 includes instructing the subject toachieve one or more values associated with one or more respirationparameters that meet or exceed one or more threshold levels associatedwith the one or more respiration parameters (not shown). In someembodiments, system 100 may be used to instruct a subject to achieve oneor more values associated with one or more respiration parameters thatmeet or exceed one or more threshold levels associated with the one ormore respiration parameters. In some embodiments, one or moreperformance indicators 116 may be configured to instruct a subject toachieve one or more values associated with one or more respirationparameters that meet or exceed one or more threshold levels associatedwith the one or more respiration parameters. For example, in someembodiments, a flow sensor 124 may assess a value associated with flowthrough one or more flow channels 104 disposed within an inhaler duringan inhalation cycle by a subject using the inhaler. The flow sensor 124may transmit one or more signals 112 that include the assessed value toa performance indicator 116. If the assessed value does not meet aminimum threshold value for flow, the performance indicator 116 mayinstruct the subject to increase flow through the one or more flowchannels 104 during the inhalation cycle. In another example, a timer134 may assess a breath holding period following an inhalation cycle andtransmit one or more signals 112 that include the assessed value to aperformance indicator 116. If the assessed breath holding value is belowa breath holding threshold value the performance indicator 116 mayinstruct a subject to increase their breath holding period after aninhalation cycle. A performance indicator 116 may provide instructionsto a subject in numerous formats. For example, in some embodiments, aperformance indicator 116 may provide audible instructions. In someembodiments, a performance indicator 116 may provide visualinstructions. In some embodiments, a performance indicator 116 mayprovide tactile instructions.

In some embodiments, operation 1240 includes instructing the subject toachieve one or more values associated with one or more respirationparameters that are within one or more ranges of levels associated withthe one or more respiration parameters (not shown). In some embodiments,system 100 may be used to instruct a subject to achieve one or morevalues associated with one or more respiration parameters that arewithin one or more ranges of levels associated with the one or morerespiration parameters. For example, in some embodiments, a flow sensor124 may assess a value associated with flow through one or more flowchannels 104 disposed within an inhaler during use of the inhaler by asubject. The flow sensor 124 may transmit one or more signals 112 thatinclude the assessed value to a performance indicator 116. If theassessed value is not within one or more ranges of values associatedwith one or more respiration parameters the performance indicator 116may instruct the subject to achieve one or more respiration parametersthat are within one or more ranges of levels. In another example, atimer 134 may assess a period of time that a subject inhales through aninhaler. The timer 134 may transmit one or more signals 112 that includethe assessed value to a performance indicator 116. If the assessed timeperiod value is outside the one or more ranges the performance indicator116 may instruct the subject to inhale through the inhaler for a timeperiod that is within the one or more ranges. In some embodiments, asensor 114 may assess one or more respiration parameters associated withuse of an inhaler by a subject and then transmit one or more signals 112that include the information to a control unit 108. The control unit 108may then direct a performance indicator 116 to instruct the subject toachieve one or more levels that are within one or more ranges of levels.

In some embodiments, operation 1240 includes instructing the subject toachieve one or more values associated with one or more inhalationparameters that are within one or more ranges of levels associated withthe one or more inhalation parameters (not shown). In some embodiments,system 100 may be used to instruct a subject to achieve one or morevalues associated with one or more inhalation parameters that are withinone or more ranges of levels associated with the one or more inhalationparameters. For example, in some embodiments, one or more velocimeters138 may assess one or more values associated with the velocity of flowthrough one or more flow channels 104 disposed within an inhaler duringan inhalation cycle of a subject using the inhaler. The one or morevelocimeters 138 may transmit one or more signals 112 that include theone or more values to a performance indicator 116. The performanceindicator 116 may then instruct the subject to achieve one or morevalues that are within one or more ranges of levels associated with theone or more inhalation parameters. Examples of such instructions mayinclude, but are not limited to, instructing the subject to increaseflow though the inhaler, instructing the subject to decrease flow thoughthe inhaler, instructing the subject to maintain the current level offlow though the inhaler, and the like.

In some embodiments, operation 1240 includes instructing the subject toachieve one or more values associated with one or more breath holdparameters that are within one or more ranges of levels associated withthe one or more breath hold parameters (not shown). In some embodiments,system 100 may be used to instruct a subject to achieve one or morevalues associated with one or more breath hold parameters that arewithin one or more ranges of levels associated with the one or morebreath hold parameters. Values related to numerous breath holdparameters may be assessed and used to instruct a subject to achieve oneor more values associated with one or more breath hold parameters thatare within one or more ranges of levels associated with the one or morebreath hold parameters. Examples of such breath hold parameters include,but are not limited to, a time period associated with a breath holdcycle, inhalation volume associated with a breath hold cycle, a quantityof formulation 214 that is inhaled and held during a breath hold cycle,a quantity of an incentive agent 218 that is inhaled and held during abreath hold cycle, and the like. In some embodiments, a timer 134 mayassess one or more time periods associated with a breath hold cycle. Thetimer 134 may transmit one or more signals 112 that include the one ormore assessed values to a performance indicator 116 that instructs thesubject to achieve one or more values associated with one or more breathhold periods that are within a range of levels associated with the oneor more breath hold periods. In some embodiments, a performanceindicator 116 may instruct the subject to increase the volume of flowthat is inhaled and held during a breath hold cycle. In someembodiments, a performance indicator 116 may instruct the subject todecrease the volume of flow that is inhaled and held during a breathhold cycle. In some embodiments, a sensor 114 may transmit one or moresignals 112 that include an assessed value to a control unit 108 thatdirects a performance indicator 116 to instruct the subject to achieveone or more values associated with one or more breath hold parametersthat are within a range of levels associated with the one or more breathhold parameters.

In some embodiments, operation 1240 includes instructing the subject toachieve one or more values associated with one or more exhalationparameters that are within one or more ranges of levels associated withthe one or more exhalation parameters (not shown). In some embodiments,system 100 may be used to instruct a subject to achieve one or morevalues associated with one or more exhalation parameters that are withinone or more ranges of levels associated with the one or more exhalationparameters. For example, in some embodiments, one or more velocimeters138 may assess one or more values associated with the velocity of flowthrough one or more flow channels 104 disposed within an inhaler duringan exhalation cycle of a subject using the inhaler. The one or morevelocimeters 138 may transmit one or more signals 112 that include theone or more values to a performance indicator 116 that instructs thesubject to achieve one or more values associated with one or moreexhalation parameters that are within one or more ranges of levelsassociated with the one or more exhalation parameters. Examples of suchinstructions may include, but are not limited to, instructing thesubject to increase flow though the inhaler, instructing the subject todecrease flow though the inhaler, instructing the subject to maintainthe current level of flow though the inhaler, and the like.

FIG. 13 illustrates operational flow 1300 that includes operation 1310that includes assessing one or more parameters associated with use of aninhaler by a subject, operation 1320 that includes administering atleast one active agent 214 to the subject in response to assessing theone or more parameters associated with use of the inhaler, operation1330 that includes administering at least one incentive agent 218 to thesubject in coordination with administering the at least one active agent214, and operation 1340 that includes accepting information associatedwith one or more parameters associated with the subject. Operations1310, 1320, and 1330 correspond to operations 1010, 1020, and 1030 aspreviously described with reference to FIG. 10.

In FIG. 13 and in the following description that includes variousexamples of operations used during performance of the method, discussionand explanation may be provided with respect to any one or combinationof the above-described examples, and/or with respect to other examplesand contexts. However, it should be understood that the operations maybe executed in a number of other environments and contexts, and/ormodified versions of the figures. Also, although the various operationsare presented in the sequence(s) illustrated, it should be understoodthat the various operations may be performed in other orders than thosewhich are illustrated, or may be performed concurrently.

Operation 1340 includes accepting information associated with one ormore parameters associated with the subject. In some embodiments, system100 may be used to accept information associated with one or moreparameters associated with a subject. For example, in some embodiments,a user interface 110 may accept information associated with one or moreparameters associated with a subject. In some embodiments, a controlunit 108 may accept information associated with one or more parametersassociated with a subject. In some embodiments, a performance indicator116 may accept information associated with one or more parametersassociated with a subject. Accordingly, numerous components of system100 may accept information associated with one or more parametersassociated with a subject. Numerous types of information associated withone or more parameters associated with a subject may be accepted.Examples of such information include, but are not limited to, height,weight, age, activity level, drug use, nutraceutical use, heart rate,tidal volume, dosage of a drug used by the subject, and the like.

In some embodiments, operation 1340 includes accepting informationassociated with one or more physical parameters associated with thesubject (not shown). In some embodiments, system 100 may be used toaccept information associated with one or more physical parametersassociated with a subject. For example, in some embodiments, a userinterface 110 may accept information associated with one or morephysical parameters associated with a subject. In some embodiments, acontrol unit 108 may accept information associated with one or morephysical parameters associated with a subject. In some embodiments, aperformance indicator 116 may accept information associated with one ormore physical parameters associated with a subject. Accordingly,numerous components of system 100 may accept information associated withone or more physical parameters associated with a subject. Numeroustypes of information associated with one or more physical parametersassociated with a subject may be accepted. Examples of such informationinclude, but are not limited to, height, weight, age, activity level,heart rate, tidal volume, and the like.

In some embodiments, operation 1340 includes accepting informationassociated with one or more parameters associated with the subject andusing the information in combination with one or more respirationparameters to determine one or more subject specific respirationcharacteristics (not shown). In some embodiments, system 100 may be usedto accept information associated with one or more parameters associatedwith a subject and use the information in combination with one or morerespiration parameters to determine one or more subject specificrespiration characteristics. In some embodiments, a control unit 108 mayaccept information associated with one or more parameters associatedwith a subject and use the information in combination with one or morerespiration parameters to determine one or more subject specificrespiration characteristics associated with the subject. For example, insome embodiments, a control unit 108 may accept information associatedwith the total lung capacity associated with a subject. The control unit108 may also receive one or more signals 112 that include one or moreassessed values associated with the tidal volume of the subject from oneor more sensors 114 associated with an inhaler used by the subject. Thecontrol unit 108 may then use the total lung capacity and the tidalvolume to calculate the residual volume that is specific to the subject.Accordingly, numerous subject specific respiration characteristics maybe determined. Examples of such subject specific respirationcharacteristics include, but are not limited to, total lung capacity,tidal volume, residual volume, expiratory reserve volume, inspiratoryreserve volume, inspiratory capacity, inspiratory vital capacity, vitalcapacity, function residual volume, alveolar gas volume, actual volumeof the lung, forced vital capacity, forced expiratory volume, forcedexpiratory flow, forced inspiratory flow, peak expiratory flow, maximalvoluntary ventilation, and the like.

In some embodiments, operation 1340 includes accepting informationassociated with one or more parameters associated with the subject andusing the information in combination with one or more deliveryparameters to estimate a quantity of the active agent 214 that will beeffectively delivered to the subject (not shown). In some embodiments,system 100 may be used to accept information associated with one or moreparameters associated with a subject and use the information incombination with one or more delivery parameters to estimate a quantityof an active agent 214 that will be effectively delivered to thesubject. For example, in some embodiments, a control unit 108 may acceptinformation associated with the total lung capacity of a subject. Thecontrol unit 108 may also receive one or more signals that includeinformation associated with a total volume of flow and quantity ofactive agent 214 that flowed through one or more flow channels 104 in aninhaler used by the subject during an inhalation cycle from one or moresensors 114. The control unit 108 may then estimate a quantity of activeagent 214 that was effectively delivered to the subject based on theinhaled volume and the quantity of the active agent 214 that wasdelivered.

FIG. 14 illustrates operational flow 1400 that includes operation 1410that includes assessing one or more parameters associated with use of aninhaler by a subject, operation 1420 that includes administering atleast one active agent 214 to the subject in response to assessing theone or more parameters associated with use of the inhaler, operation1430 that includes administering at least one incentive agent 218 to thesubject in coordination with administering the at least one active agent214, and operation 1440 that includes administering at least oneadditional active agent 214 to the subject. Operations 1410, 1420, and1430 correspond to operations 1010, 1020, and 1030 as previouslydescribed with reference to FIG. 10.

In FIG. 14 and in the following description that includes variousexamples of operations used during performance of the method, discussionand explanation may be provided with respect to any one or combinationof the above-described examples, and/or with respect to other examplesand contexts. However, it should be understood that the operations maybe executed in a number of other environments and contexts, and/ormodified versions of the figures. Also, although the various operationsare presented in the sequence(s) illustrated, it should be understoodthat the various operations may be performed in other orders than thosewhich are illustrated, or may be performed concurrently.

Operation 1440 includes administering at least one additional activeagent 214 to the subject. In some embodiments, system 100 may be used toadminister at least one additional active agent 214 to a subject. Forexample, in some embodiments, a control unit 108 may direct one or moreactuators 120 to facilitate at least partial release of at least oneadditional active agent 214 from one or more active agent reservoirs212. Numerous types of active agents 214 may be administered. Examplesof such active agents 214 include, but are not limited to, steroids,anti-inflammatory drugs, bronchodilators, leukotriene modifiers,long-acting beta antagonists, 1,3-dimethylxanthine, short-acting betaagonists,[8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]oct-3-yl]3-hydroxy-2-phenyl-propanoate,antibodies, and the like (see e.g., Remingtion: The Science and Practiceof Pharmacy, Lippincott, Williams & Wilkins, 20th edition, Baltimore,Md., USA (2000), Physicians' Desk Reference, Thomson PDR, 58th edition,Montvale, N.J. (2004); Merck Index, Merck and Co., 13th edition,Whitehouse Station, N.J. (2001); which are hereby incorporated byreference). Accordingly, numerous combinations of active agents 214 maybe administered to a subject.

In some embodiments, operation 1440 includes administering at least onepulmonary vasodilator (not shown). In some embodiments, system 100 maybe used to administer at least one pulmonary vasodilator. For example,in some embodiments, a control unit 108 may direct one or more actuators120 to facilitate at least partial release of one or more pulmonaryvasodilators from one or more active agent reservoirs 212. Examples ofpulmonary vasodilators include, but are not limited to, endothelinreceptor antagonists, phosphodiesterase type 5 (PDE-5) inhibitors,prostacyclin derivatives, and5-{(E)-(1S,5S,6R,7R)-7-hydroxy-6[(E)-(3S,4RS)-3-hydroxy-4-methyl-1-octen-6-inyl]-bicyclo[3.3.0]octan-3-ylidene}pentanoicacid.

In some embodiments, operation 1440 includes administering at least oneanti-inflammatory agent (not shown). In some embodiments, system 100 maybe used to administer at least one anti-inflammatory agent. For example,in some embodiments, a control unit 108 may direct one or more actuators120 to facilitate at least partial release of one or moreanti-inflammatory agents from one or more active agent reservoirs 212.Examples of anti-inflammatory agents include, but are not limited to,beclomethasone dipropionate, fluticasione propionate, flunisolide,budesonide, mometasone, ciclesonide, cromolyn sodium, and nedocromilsodium.

FIG. 15 illustrates operational flow 1500 that includes operation 1510that includes assessing one or more parameters associated with use of aninhaler by a subject, operation 1520 that includes administering atleast one active agent 214 to the subject in response to assessing theone or more parameters associated with use of the inhaler, operation1530 that includes administering at least one incentive agent 218 to thesubject in coordination with administering the at least one active agent214, and operation 1540 that includes assessing one or more parametersassociated with administering the at least one active agent 214 to thesubject. Operations 1510, 1520, and 1530 correspond to operations 1010,1020, and 1030 as previously described with reference to FIG. 10.

In FIG. 15 and in the following description that includes variousexamples of operations used during performance of the method, discussionand explanation may be provided with respect to any one or combinationof the above-described examples, and/or with respect to other examplesand contexts. However, it should be understood that the operations maybe executed in a number of other environments and contexts, and/ormodified versions of the figures. Also, although the various operationsare presented in the sequence(s) illustrated, it should be understoodthat the various operations may be performed in other orders than thosewhich are illustrated, or may be performed concurrently.

Operation 1540 includes assessing one or more parameters associated withadministering the at least one active agent 214 to the subject. In someembodiments, system 100 may be used to assess one or more parametersassociated with administering at least one active agent 214 to thesubject. For example, in some embodiments, an optical sensor 126 may beused to assess a quantity of one or more active agents 214 that flowthrough one or more flow channels 104 that are disposed within aninhaler during use of the inhaler by a subject. In some embodiments, avelocimeter 138 may be used to assess the velocity with which one ormore active agents 214 flow through one or more flow channels 104 thatare disposed within an inhaler during use of the inhaler by a subject.Accordingly, numerous parameters may be determined that are associatedwith administration of one or more active agents 214 to a subject.

In some embodiments, operation 1540 includes assessing one or moreparameters associated with a velocity with which the at least one activeagent 214 was administered to the subject (not shown). In someembodiments, system 100 may be used to assess one or more parametersassociated with a velocity with which at least one active agent 214 wasadministered to a subject. For example, in some embodiments, avelocimeter 138 may be used to assess the velocity with which one ormore active agents 214 flow through one or more flow channels 104 thatare disposed within an inhaler during use of the inhaler by a subject.

In some embodiments, operation 1540 includes assessing one or moreparameters associated with a volume of gas in which the at least oneactive agent 214 was administered to the subject (not shown). In someembodiments, system 100 may be used to assess one or more parametersassociated with a volume of gas in which at least one active agent 214was administered to a subject. For example, in some embodiments, avolume sensor 128 may be used to assess a volume of gas in which one ormore active agents 214 flow through one or more flow channels 104disposed within an inhaler when the inhaler is used by a subject.

In some embodiments, operation 1540 includes assessing a time periodassociated with administering the at least one active agent 214 to thesubject (not shown). In some embodiments, system 100 may be used toassess a time period associated with administering at least one activeagent 214 to a subject. For example, in some embodiments, a timer 134may be used to assess a time period in which one or more active agents214 are administered through one or more flow channels 104 disposedwithin an inhaler when the inhaler is used by a subject.

In some embodiments, operation 1540 includes assessing a quantity of theat least one active agent 214 that was administered to the subject (notshown). In some embodiments, system 100 may be used to assess a quantityof at least one active agent 214 that was administered to a subject. Insome embodiments, an optical sensor 126 may be used to assess a quantityof one or more active agents 214 that flow through one or more flowchannels 104 disposed within an inhaler that is used by a subject. Insome embodiments, a phase Doppler interferometer 136 may be used toassess a quantity of one or more active agents 214 that flow through oneor more flow channels 104 disposed within an inhaler that is used by asubject. In some embodiments, an ultrasonic flow meter 140 may be usedto assess a quantity of one or more active agents 214 that flow throughone or more flow channels 104 disposed within an inhaler that is used bya subject. In some embodiments, a sensor 114 may transmit one or moresignals 112 that include one or more assessed values associated with aquantity of one or more active agents 214 to a control unit 108 thatreceives the one or more assessed values and then determines a quantityof one or more active agents 214 that were delivered to a subject usingan inhaler.

In some embodiments, operation 1540 includes assessing a quantity of theat least one active agent 214 that was administered to the subject andthen repeating the administration of the at least one active agent 214until a preselected quantity of the at least one active agent 214 isadministered to the subject (not shown). In some embodiments, system 100may be used to assess a quantity of at least one active agent 214 thatwas administered to a subject and then repeat administration of the atleast one active agent 214 until a preselected quantity of the at leastone active agent 214 is administered to the subject. In someembodiments, an optical sensor 126 may be used to assess a quantity ofone or more active agents 214 that flow through one or more flowchannels 104 disposed within an inhaler that is used by a subject. Insome embodiments, a phase Doppler interferometer 136 may be used toassess a quantity of one or more active agents 214 that flow through oneor more flow channels 106 disposed within an inhaler that is used by asubject. In some embodiments, an ultrasonic flow meter 140 may be usedto assess a quantity of one or more active agents 214 that flow throughone or more flow channels 104 disposed within an inhaler that is used bya subject. In some embodiments, a sensor 114 may transmit one or moresignals 112 that include one or more assessed values associated with aquantity of one or more active agents 214 to a control unit 108 thatreceives the one or more assessed values and then determines a quantityof one or more active agents 214 that were delivered to a subject usingthe inhaler. The control unit 108 may then assess the quantity of one ormore active agents 214 that were delivered to a subject using theinhaler and determine an additional quantity of the one or more activeagents 214 that are to be delivered to the subject to reach apreselected quantity of the one or more active agents 214 for delivery.The control unit 108 may then direct one or more actuators 120 tofacilitate at least partial release of one or more active agents 214from one or more active agent reservoirs 212 until the preselectedquantity of the one or more active agents 214 are administered to thesubject.

FIG. 16 illustrates operational flow 1600 that includes operation 1610that includes assessing one or more parameters associated with use of aninhaler by a subject, operation 1620 that includes administering atleast one active agent 214 to the subject in response to assessing theone or more parameters associated with use of the inhaler, operation1630 that includes administering at least one incentive agent 218 to thesubject in coordination with administering the at least one active agent214, and operation 1640 that includes assessing one or more parametersassociated with administering the at least one incentive agent 218 tothe subject. Operations 1610, 1620, and 1630 correspond to operations1010, 1020, and 1030 as previously described with reference to FIG. 10.

In FIG. 16 and in the following description that includes variousexamples of operations used during performance of the method, discussionand explanation may be provided with respect to any one or combinationof the above-described examples, and/or with respect to other examplesand contexts. However, it should be understood that the operations maybe executed in a number of other environments and contexts, and/ormodified versions of the figures. Also, although the various operationsare presented in the sequence(s) illustrated, it should be understoodthat the various operations may be performed in other orders than thosewhich are illustrated, or may be performed concurrently.

Operation 1640 includes assessing one or more parameters associated withadministering the at least one incentive agent 218 to the subject. Insome embodiments, system 100 may be used to assess one or moreparameters associated with administering at least one incentive agent218 to the subject. For example, in some embodiments, an optical sensor126 may be used to assess a quantity of one or more incentive agents 218that flow through one or more flow channels 104 that are disposed withinan inhaler during use of the inhaler by a subject. In some embodiments,a velocimeter 138 may be used to assess the velocity with which one ormore incentive agents 218 flow through one or more flow channels 104that are disposed within an inhaler during use of the inhaler by asubject. Accordingly, numerous parameters may be determined that areassociated with administration of one or more incentive agents 218 to asubject.

In some embodiments, operation 1640 includes assessing one or moreparameters associated with a velocity with which the at least oneincentive agent 218 was administered to the subject (not shown). In someembodiments, system 100 may be used to assess one or more parametersassociated with a velocity with which at least one incentive agent 218was administered to a subject. For example, in some embodiments, avelocimeter 138 may be used to assess the velocity with which one ormore incentive agents 218 flow through one or more flow channels 104that are disposed within an inhaler during use of the inhaler by asubject.

In some embodiments, operation 1640 includes assessing one or moreparameters associated with a volume of gas in which the at least oneincentive agent 218 was administered to the subject (not shown). In someembodiments, system 100 may be used to assess one or more parametersassociated with a volume of gas in which at least one incentive agent218 was administered to a subject. For example, in some embodiments, avolume sensor 128 may be used to assess a volume of gas in which one ormore incentive agents 218 flow through one or more flow channels 104disposed within an inhaler when the inhaler is used by a subject.

In some embodiments, operation 1640 includes assessing a time periodassociated with administering the at least incentive agent 218 to thesubject (not shown). In some embodiments, system 100 may be used toassess a time period associated with administering at least oneincentive agent 218 to a subject. For example, in some embodiments, atimer 134 may be used to assess a time period in which one or moreincentive agents 218 are administered through one or more flow channels104 disposed within an inhaler when the inhaler is used by a subject.

In some embodiments, operation 1640 includes assessing a quantity of theat least one incentive agent 218 that was administered to the subject(not shown). In some embodiments, system 100 may be used to assess aquantity of at least one incentive agent 218 that was administered to asubject. In some embodiments, an optical sensor 126 may be used toassess a quantity of one or more incentive agents 218 that flow throughone or more flow channels 104 disposed within an inhaler that is used bya subject. In some embodiments, a phase Doppler interferometer 136 maybe used to assess a quantity of one or more incentive agents 218 thatflow through one or more flow channels 104 disposed within an inhalerthat is used by a subject. In some embodiments, an ultrasonic flow meter140 may be used to assess a quantity of one or more incentive agents 218that flow through one or more flow channels 104 disposed within aninhaler that is used by a subject. In some embodiments, a sensor 114 maytransmit one or more signals 112 that include one or more assessedvalues associated with a quantity of one or more incentive agents 218 toa control unit 108 that receives the one or more assessed values andthen determines a quantity of one or more incentive agents 218 that weredelivered to a subject using an inhaler.

In some embodiments, operation 1640 includes assessing a quantity of theat least one incentive agent 218 that was administered to the subjectand then repeating the administration of the at least one incentiveagent 218 until a preselected quantity of the at least one active agent214 is administered to the subject (not shown). In some embodiments,system 100 may be used to assess a quantity of at least one incentiveagent 218 that was administered to a subject and then repeatadministration of the at least one incentive agent 218 until apreselected quantity of the at least one incentive agent 218 isadministered to the subject. In some embodiments, an optical sensor 126may be used to assess a quantity of one or more incentive agents 218that flow through one or more flow channels 104 disposed within aninhaler that is used by a subject. In some embodiments, a phase Dopplerinterferometer 136 may be used to assess a quantity of one or moreincentive agents 218 that flow through one or more flow channels 106disposed within an inhaler that is used by a subject. In someembodiments, an ultrasonic flow meter 140 may be used to assess aquantity of one or more incentive agents 218 that flow through one ormore flow channels 104 disposed within an inhaler that is used by asubject. In some embodiments, a sensor 114 may transmit one or moresignals 112 that include one or more assessed values associated with aquantity of one or more incentive agents 218 to a control unit 108 thatreceives the one or more assessed values and then determines a quantityof one or more incentive agents 218 that were delivered to a subjectusing the inhaler. The control unit 108 may then assess the quantity ofone or more incentive agents 218 that were delivered to a subject usingthe inhaler and determine an additional quantity of the one or moreincentive agents 218 that are to be delivered to the subject to reach apreselected quantity of the one or more incentive agents 218 fordelivery. The control unit 108 may then direct one or more actuators 120to facilitate at least partial release of one or more incentive agents218 from one or more incentive agent reservoirs 216 until thepreselected quantity of the one or more incentive agents 218 areadministered to the subject.

FIG. 17 illustrates operational flow 1700 that includes operation 1710that includes assessing one or more parameters associated with use of aninhaler by a subject, operation 1720 that includes administering atleast one active agent 214 to the subject in response to assessing theone or more parameters associated with use of the inhaler, operation1730 that includes administering at least one incentive agent 218 to thesubject in coordination with administering the at least one active agent214, operation 1740 that includes assessing one or more parametersassociated with administering the at least one active agent 214 to thesubject, and operation 1750 that includes predicting one or morelocations in the pulmonary tract of the subject where the at least oneactive agent 214 was delivered in response to the one or more parametersassociated with administration of the at least one active agent 214 tothe subject. Operations 1710, 1720, and 1730 correspond to operations1010, 1020, and 1030 as previously described with reference to FIG. 10and operation 1740 corresponds to operation 1540 as previously describedwith reference to FIG. 15.

In FIG. 17 and in the following description that includes variousexamples of operations used during performance of the method, discussionand explanation may be provided with respect to any one or combinationof the above-described examples, and/or with respect to other examplesand contexts. However, it should be understood that the operations maybe executed in a number of other environments and contexts, and/ormodified versions of the figures. Also, although the various operationsare presented in the sequence(s) illustrated, it should be understoodthat the various operations may be performed in other orders than thosewhich are illustrated, or may be performed concurrently.

Operation 1750 includes predicting one or more locations in thepulmonary tract of the subject where the at least one active agent 214was delivered in response to the one or more parameters associated withadministration of the at least one active agent 214 to the subject. Insome embodiments, system 100 may be used to predict one or morelocations in the pulmonary tract of a subject where at least one activeagent 214 was delivered in response to one or more parameters associatedwith administration of the at least one active agent 214 to the subject.For example, in some embodiments, a flow sensor 124 may be used tomeasure a volume of flow through one or more flow channels 104 disposedwithin an inhaler during an inhalation cycle by a subject using theinhaler to administer one or more active agents 214. The flow sensor 124may transmit one or more signals that include an assessed value for thevolume of flow through the inhaler to a control unit 108. The controlunit 108 may then compare the assessed volume of flow to the total lungcapacity of the subject using the inhaler. The control unit 108 may thenpredict one or more locations in the pulmonary tract of the subjectwhere the at least one active agent 214 was delivered based on thecomparison of assessed volume of flow to total lung capacity of thesubject. For example, if the assessed volume of flow is nearly equal tothe total lung capacity of the subject, the control unit 108 may predictthat the active agent 214 was administered to deep lung tissue. Incontrast, if the assessed volume of flow is a small fraction of thetotal lung capacity of the subject, the control unit 108 may predictthat the active agent 214 was administered to shallow lung tissue.

In some embodiments, operation 1750 includes predicting a quantity ofthe at least one active agent 214 delivered to one or more locations inthe pulmonary tract of the subject and then repeating the administrationof the at least one active agent 214 until a preselected quantity of theat least one active agent 214 is predicted to have been administered tothe subject (not shown). In some embodiments, system 100 may be used topredict a quantity of at least one active agent 214 delivered to one ormore locations in the pulmonary tract of a subject and then repeatadministration of the at least one active agent 214 until a preselectedquantity of the at least one active agent 214 is predicted to have beenadministered to the subject. For example, in some embodiments, sensors114 may be used to assess a volume of flow and a quantity of one or moreactive agents 214 flowing through one or more flow channels 104 disposedwithin an inhaler during an inhalation cycle by a subject using theinhaler to administer the one or more active agents 214. The sensors 114may transmit one or more signals 112 that include one or more assessedvalues corresponding to the volume of flow and the quantity of activeagent 214 flowing through the inhaler to a control unit 108. The controlunit 108 may then compare the assessed volume of flow to the total lungcapacity of the subject using the inhaler. The control unit 108 may thenpredict one or more locations in the pulmonary tract of the subjectwhere the one or more active agents 214 were delivered based on thecomparison of assessed volume of flow to total lung capacity of thesubject. The control unit 108 may also predict the quantity of the oneor more active agents 214 that were delivered to the location in thepulmonary tract based on the assessed quantity of the one or more activeagents 214. For example, if the assessed volume of flow is a smallfraction of the total lung capacity of the subject, the control unit 108may predict that the assessed quantity of the one or more active agents214 were administered to shallow lung tissue. In contrast, if theassessed volume of flow is nearly equal to the total lung capacity ofthe subject, the control unit 108 may predict that the assessed quantityof the one or more active agents 214 were administered throughout thepulmonary tract. The control unit 108 may then compare the quantity ofthe one or more active agents 214 that were administered to the subjectto a preselected quantity of the one or more active agents 214 that areto be administered to the subject to determine an additional quantity ofone or more active agents 214 for administration to the subject. Thecontrol unit 108 may then direct one or more actuators 120 to facilitateat least partial release from one or more active agent reservoirs 212 toadminister the one or more active agents 214 to the subject until apreselected quantity of the one or more active agents 214 have beenadministered to the subject. In some embodiments, a control unit 108 maydirect one or more actuators 120 to facilitate at least partial releasefrom one or more active agent reservoirs 122 at selected stages of aninhalation cycle through an inhaler by a subject. For example, in someembodiments, a control unit 108 may direct one or more actuators 120 tofacilitate at least partial release from one or more active agentreservoirs 212 during an early stage of an inhalation cycle toadminister one or more active agents 214 to deep lung tissue in thepulmonary tract. In some embodiments, a control unit 108 may direct oneor more actuators 120 to facilitate at least partial release from one ormore active agent reservoirs 212 during a late stage of an inhalationcycle to administer one or more active agents 214 to shallow lung tissuein the pulmonary tract. Accordingly, in some embodiments, the quantityof one or more active agents 214 and the location in the pulmonary tractto which the one or more active agents 214 are administered may becontrolled.

FIG. 18 illustrates operational flow 1800 that includes operation 1810that includes assessing one or more parameters associated with use of aninhaler by a subject, operation 1820 that includes administering atleast one active agent 214 to the subject in response to assessing theone or more parameters associated with use of the inhaler, operation1830 that includes administering at least one incentive agent 218 to thesubject in coordination with administering the at least one active agent214, operation 1840 that includes assessing one or more parametersassociated with administering the at least one active agent 214 to thesubject, and operation 1850 that includes predicting one or morelocations in the pulmonary tract of the subject where the at least oneactive agent 214 was delivered in response to the one or more parametersassociated with administration of the at least one active agent 214 tothe subject. Operations 1810, 1820, and 1830 correspond to operations1010, 1020, and 1030 as previously described with reference to FIG. 10and operation 1840 corresponds to operation 1640 as previously describedwith reference to FIG. 16.

In FIG. 18 and in the following description that includes variousexamples of operations used during performance of the method, discussionand explanation may be provided with respect to any one or combinationof the above-described examples, and/or with respect to other examplesand contexts. However, it should be understood that the operations maybe executed in a number of other environments and contexts, and/ormodified versions of the figures. Also, although the various operationsare presented in the sequence(s) illustrated, it should be understoodthat the various operations may be performed in other orders than thosewhich are illustrated, or may be performed concurrently.

Operation 1850 includes predicting one or more locations in thepulmonary tract of the subject where the at least one incentive agent218 was delivered in response to the one or more parameters associatedwith administration of the at least one incentive agent 218 to thesubject. In some embodiments, system 100 may be used to predict one ormore locations in the pulmonary tract of a subject where at least oneincentive agent 218 was delivered in response to one or more parametersassociated with administration of the at least one incentive agent 218to the subject. For example, in some embodiments, a flow sensor 124 maybe used to measure a volume of flow through one or more flow channels104 disposed within an inhaler during an inhalation cycle by a subjectusing the inhaler to administer one or more incentive agents 218. Theflow sensor 124 may transmit one or more signals that include anassessed value for the volume of flow through the inhaler to a controlunit 108. The control unit 108 may then compare the assessed volume offlow to the total lung capacity of the subject using the inhaler. Thecontrol unit 108 may then predict one or more locations in the pulmonarytract of the subject where the at least one incentive agent 218 wasdelivered based on the comparison of assessed volume of flow to totallung capacity of the subject. For example, if the assessed volume offlow is nearly equal to the total lung capacity of the subject, thecontrol unit 108 may predict that the incentive agent 218 wasadministered to deep lung tissue. In contrast, if the assessed volume offlow is a small fraction of the total lung capacity of the subject, thecontrol unit 108 may predict that the incentive agent 218 wasadministered to shallow lung tissue.

In some embodiments, operation 1850 includes predicting a quantity ofthe at least one incentive agent 218 delivered to one or more locationsin the pulmonary tract of the subject and then repeating theadministration of the at least one incentive agent 218 until apreselected quantity of the at least one incentive agent 218 ispredicted to have been administered to the subject (not shown). In someembodiments, system 100 may be used to predict a quantity of at leastone incentive agent 218 delivered to one or more locations in thepulmonary tract of a subject and then repeat administration of the atleast one incentive agent 218 until a preselected quantity of the atleast incentive agent 218 is predicted to have been administered to thesubject. For example, in some embodiments, sensors 114 may be used toassess a volume of flow and a quantity of one or more incentive agents218 flowing through one or more flow channels 104 disposed within aninhaler during an inhalation cycle by a subject using the inhaler toadminister the one or more incentive agents 218. The sensors 114 maytransmit one or more signals 112 that include one or more assessedvalues corresponding to the volume of flow and the quantity of incentiveagent 218 flowing through the inhaler to a control unit 108. The controlunit 108 may then compare the assessed volume of flow to the total lungcapacity of the subject using the inhaler. The control unit 108 may thenpredict one or more locations in the pulmonary tract of the subjectwhere the one or more incentive agents 218 were delivered based on thecomparison of assessed volume of flow to total lung capacity of thesubject. The control unit 108 may also predict the quantity of the oneor more incentive agents 218 that were delivered to the location in thepulmonary tract based on the assessed quantity of the one or moreincentive agents 218. For example, if the assessed volume of flow is asmall fraction of the total lung capacity of the subject, the controlunit 108 may predict that the assessed quantity of the one or moreincentive agents 218 were administered to shallow lung tissue. Incontrast, if the assessed volume of flow is nearly equal to the totallung capacity of the subject, the control unit 108 may predict that theassessed quantity of the one or more incentive agents 218 wereadministered throughout the pulmonary tract. The control unit 108 maythen compare the quantity of the one or more incentive agents 218 thatwere administered to the subject to a preselected quantity of the one ormore incentive agents 218 that are to be administered to the subject todetermine an additional quantity of one or more incentive agents 218 foradministration to the subject. The control unit 108 may then direct oneor more actuators 120 to facilitate at least partial release from one ormore incentive agent reservoirs 216 to administer the one or moreincentive agents 218 to the subject until a preselected quantity of theone or more incentive agents 218 have been administered to the subject.In some embodiments, a control unit 108 may direct one or more actuators120 to facilitate at least partial release from one or more incentiveagent reservoirs 216 at selected stages of an inhalation cycle throughan inhaler by a subject. For example, in some embodiments, a controlunit 108 may direct one or more actuators 120 to facilitate at leastpartial release from one or more incentive agent reservoirs 216 duringan early stage of an inhalation cycle to administer one or moreincentive agents 218 to deep lung tissue in the pulmonary tract. In someembodiments, a control unit 108 may direct one or more actuators 120 tofacilitate at least partial release from one or more incentive agentreservoirs 216 during a late stage of an inhalation cycle to administerone or more incentive agents 218 to shallow lung tissue in the pulmonarytract. Accordingly, in some embodiments, the quantity of one or moreincentive agents 218 and the location in the pulmonary tract to whichthe one or more incentive agents 218 are administered may be controlled.

In some embodiments, a system that includes a computer program forexecuting a computer process on a computing device may be used tocontrol an inhaler. In some embodiments, such a system is provided thatincludes a non-transitory signal-bearing medium bearing one or moreinstructions that, when executed by one or more processing components,direct performance of operations that include at least: assessing one ormore parameters associated with use of an inhaler by a subject,administering at least one active agent to the subject in response toassessing the one or more parameters associated with use of the inhaler,and administering at least one incentive agent to the subject incoordination with administering the at least one active agent.

In some embodiments, the non-transitory signal-bearing medium mayfurther include one or more instructions that direct performance of anoperation that includes at least displaying a comparison of an assessedvalue associated with one or more respiration parameters with one ormore levels associated with the one or more respiration parameters.

In some embodiments, the non-transitory signal-bearing medium mayfurther include one or more instructions that direct performance of anoperation that includes at least instructing the subject to achieve oneor more values associated with one or more respiration parameters.

In some embodiments, the non-transitory signal-bearing medium mayfurther include one or more instructions that direct performance of anoperation that includes at least accepting information associated withone or more parameters associated with the subject.

In some embodiments, the non-transitory signal-bearing medium mayfurther include one or more instructions that direct performance of anoperation that includes at least assessing one or more parametersassociated with administering the at least one active agent to thesubject.

In some embodiments, the non-transitory signal-bearing medium mayfurther include one or more instructions that direct performance of anoperation that includes at least assessing one or more parametersassociated with administering the at least one incentive agent to thesubject.

In some embodiments, the non-transitory signal-bearing medium mayfurther include one or more instructions that direct performance of anoperation that includes at least predicting one or more locations in thepulmonary tract of the subject where the at least one active agent wasdelivered in response to the one or more parameters associated withadministration of the at least one active agent to the subject.

In some embodiments, the non-transitory signal-bearing medium mayfurther include one or more instructions that direct performance of anoperation that includes at least predicting one or more locations in thepulmonary tract of the subject where the at least one incentive agentwas delivered in response to the one or more parameters associated withadministration of the at least one incentive agent to the subject.

The one or more instructions may be, for example, computer executableand/or logic-implemented instructions. In some embodiments, the anon-transitory signal-bearing medium may include a computer-readablemedium. In some embodiments, the a non-transitory signal-bearing mediummay include a recordable medium. In some embodiments, the anon-transitory signal-bearing medium may include a communicationsmedium.

One skilled in the art will recognize that the herein describedcomponents (e.g., operations), devices, objects, and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are contemplated.Consequently, as used herein, the specific exemplars set forth and theaccompanying discussion are intended to be representative of their moregeneral classes. In general, use of any specific exemplar is intended tobe representative of its class, and the non-inclusion of specificcomponents (e.g., operations), devices, and objects should not be takenlimiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations are not expressly set forth herein for sakeof clarity.

In some instances, one or more components may be referred to herein as“configured to,” “configured by,” “configurable to,” “operable/operativeto,” “adapted/adaptable,” “able to,” “conformable/conformed to,” etc.Those skilled in the art will recognize that such terms (e.g.“configured to”) generally encompass active-state components and/orinactive-state components and/or standby-state components, unlesscontext requires otherwise.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationsmay be made without departing from the subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of the subject matter described herein.It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flows are presented in asequence(s), it should be understood that the various operations may beperformed in other orders than those which are illustrated, or may beperformed concurrently. Examples of such alternate orderings may includeoverlapping, interleaved, interrupted, reordered, incremental,preparatory, supplemental, simultaneous, reverse, or other variantorderings, unless context dictates otherwise. Furthermore, terms like“responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

Those having skill in the art will recognize that the state of the arthas progressed to the point where there is little distinction leftbetween hardware, software, and/or firmware implementations of aspectsof systems; the use of hardware, software, and/or firmware is generally(but not always, in that in certain contexts the choice between hardwareand software can become significant) a design choice representing costvs. efficiency tradeoffs. Those having skill in the art will appreciatethat there are various vehicles by which processes and/or systems and/orother technologies described herein can be effected (e.g., hardware,software, and/or firmware), and that the preferred vehicle will varywith the context in which the processes and/or systems and/or othertechnologies are deployed. For example, if an implementer determinesthat speed and accuracy are paramount, the implementer may opt for amainly hardware and/or firmware vehicle; alternatively, if flexibilityis paramount, the implementer may opt for a mainly softwareimplementation; or, yet again alternatively, the implementer may opt forsome combination of hardware, software, and/or firmware in one or moremachines, compositions of matter, and articles of manufacture, limitedto patentable subject matter under 35 USC 101. Hence, there are severalpossible vehicles by which the processes and/or devices and/or othertechnologies described herein may be effected, none of which isinherently superior to the other in that any vehicle to be utilized is achoice dependent upon the context in which the vehicle will be deployedand the specific concerns (e.g., speed, flexibility, or predictability)of the implementer, any of which may vary. Those skilled in the art willrecognize that optical aspects of implementations will typically employoptically-oriented hardware, software, and or firmware.

In some implementations described herein, logic and similarimplementations may include computer programs or other controlstructures. Electronic circuitry, for example, may have one or morepaths of electrical current constructed and arranged to implementvarious functions as described herein. In some implementations, one ormore media may be configured to bear a device-detectable implementationwhen such media hold or transmit device detectable instructions operableto perform as described herein. In some variants, for example,implementations may include an update or modification of existingsoftware or firmware, or of gate arrays or programmable hardware, suchas by performing a reception of or a transmission of one or moreinstructions in relation to one or more operations described herein.Alternatively or additionally, in some variants, an implementation mayinclude special-purpose hardware, software, firmware components, and/orgeneral-purpose components executing or otherwise invokingspecial-purpose components. Specifications or other implementations maybe transmitted by one or more instances of tangible transmission mediaas described herein, optionally by packet transmission or otherwise bypassing through distributed media at various times.

Alternatively or additionally, implementations may include executing aspecial-purpose instruction sequence or invoking circuitry for enabling,triggering, coordinating, requesting, or otherwise causing one or moreoccurrences of virtually any functional operation described herein. Insome variants, operational or other logical descriptions herein may beexpressed as source code and compiled or otherwise invoked as anexecutable instruction sequence. In some contexts, for example,implementations may be provided, in whole or in part, by source code,such as C++, or other code sequences. In other implementations, sourceor other code implementation, using commercially available and/ortechniques in the art, may be compiled//implemented/translated/convertedinto a high-level descriptor language (e.g., initially implementingdescribed technologies in C or C++ programming language and thereafterconverting the programming language implementation into alogic-synthesizable language implementation, a hardware descriptionlanguage implementation, a hardware design simulation implementation,and/or other such similar mode(s) of expression). For example, some orall of a logical expression (e.g., computer programming languageimplementation) may be manifested as a Verilog-type hardware description(e.g., via Hardware Description Language (HDL) and/or Very High SpeedIntegrated Circuit Hardware Descriptor Language (VHDL)) or othercircuitry model which may then be used to create a physicalimplementation having hardware (e.g., an Application Specific IntegratedCircuit). Those skilled in the art will recognize how to obtain,configure, and optimize suitable transmission or computational elements,material supplies, actuators, or other structures in light of theseteachings.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, or examples can be implemented,individually and/or collectively, by a wide range of hardware, software,firmware, or virtually any combination thereof, limited to patentablesubject matter under 35 U.S.C. 101. In an embodiment, several portionsof the subject matter described herein may be implemented viaApplication Specific Integrated Circuits (ASICs), Field ProgrammableGate Arrays (FPGAs), digital signal processors (DSPs), or otherintegrated formats. However, those skilled in the art will recognizethat some aspects of the embodiments disclosed herein, in whole or inpart, can be equivalently implemented in integrated circuits, as one ormore computer programs running on one or more computers (e.g., as one ormore programs running on one or more computer systems), as one or moreprograms running on one or more processors (e.g., as one or moreprograms running on one or more microprocessors), as firmware, or asvirtually any combination thereof, limited to patentable subject matterunder 35 U.S.C. 101, and that designing the circuitry and/or writing thecode for the software and or firmware would be well within the skill ofone of skill in the art in light of this disclosure. In addition, thoseskilled in the art will appreciate that the mechanisms of the subjectmatter described herein are capable of being distributed as a programproduct in a variety of forms, and that an illustrative embodiment ofthe subject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution. Examples of a signal bearing medium include, but are notlimited to, the following: a recordable type medium such as a floppydisk, a hard disk drive, a Compact Disc (CD), a Digital Video Disk(DVD), a digital tape, a computer memory, etc.; and a transmission typemedium such as a digital and/or an analog communication medium (e.g., afiber optic cable, a waveguide, a wired communications link, a wirelesscommunication link (e.g., transmitter, receiver, transmission logic,reception logic, etc.), etc.).

In a general sense, those skilled in the art will recognize that thevarious embodiments described herein can be implemented, individuallyand/or collectively, by various types of electro-mechanical systemshaving a wide range of electrical components such as hardware, software,firmware, and/or virtually any combination thereof, limited topatentable subject matter under 35 U.S.C. 101; and a wide range ofcomponents that may impart mechanical force or motion such as rigidbodies, spring or torsional bodies, hydraulics, electro-magneticallyactuated devices, and/or virtually any combination thereof.Consequently, as used herein “electro-mechanical system” includes, butis not limited to, electrical circuitry operably coupled with atransducer (e.g., an actuator, a motor, a piezoelectric crystal, a MicroElectro Mechanical System (MEMS), etc.), electrical circuitry having atleast one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes and/or devices described herein,or a microprocessor configured by a computer program which at leastpartially carries out processes and/or devices described herein),electrical circuitry forming a memory device (e.g., forms of memory(e.g., random access, flash, read only, etc.)), electrical circuitryforming a communications device (e.g., a modem, communications switch,optical-electrical equipment, etc.), and/or any non-electrical analogthereto, such as optical or other analogs (e.g., graphene basedcircuitry). Those skilled in the art will also appreciate that examplesof electro-mechanical systems include but are not limited to a varietyof consumer electronics systems, medical devices, as well as othersystems such as motorized transport systems, factory automation systems,security systems, and/or communication/computing systems. Those skilledin the art will recognize that electro-mechanical as used herein is notnecessarily limited to a system that has both electrical and mechanicalactuation except as context may dictate otherwise.

In a general sense, those skilled in the art will recognize that thevarious aspects described herein which can be implemented, individuallyand/or collectively, by a wide range of hardware, software, firmware,and/or any combination thereof can be viewed as being composed ofvarious types of “electrical circuitry.” Consequently, as used herein“electrical circuitry” includes, but is not limited to, electricalcircuitry having at least one discrete electrical circuit, electricalcircuitry having at least one integrated circuit, electrical circuitryhaving at least one application specific integrated circuit, electricalcircuitry forming a general purpose computing device configured by acomputer program (e.g., a general purpose computer configured by acomputer program which at least partially carries out processes and/ordevices described herein, or a microprocessor configured by a computerprogram which at least partially carries out processes and/or devicesdescribed herein), electrical circuitry forming a memory device (e.g.,forms of memory (e.g., random access, flash, read only, etc.)), and/orelectrical circuitry forming a communications device (e.g., a modem,communications switch, optical-electrical equipment, etc.). Those havingskill in the art will recognize that the subject matter described hereinmay be implemented in an analog or digital fashion or some combinationthereof.

Those skilled in the art will recognize that at least a portion of thedevices and/or processes described herein can be integrated into animage processing system. Those having skill in the art will recognizethat a typical image processing system generally includes one or more ofa system unit housing, a video display device, memory such as volatileor non-volatile memory, processors such as microprocessors or digitalsignal processors, computational entities such as operating systems,drivers, applications programs, one or more interaction devices (e.g., atouch pad, a touch screen, an antenna, etc.), control systems includingfeedback loops and control motors (e.g., feedback for sensing lensposition and/or velocity; control motors for moving/distorting lenses togive desired focuses). An image processing system may be implementedutilizing suitable commercially available components, such as thosetypically found in digital still systems and/or digital motion systems.

Those skilled in the art will recognize that at least a portion of thedevices and/or processes described herein can be integrated into a dataprocessing system. Those having skill in the art will recognize that adata processing system generally includes one or more of a system unithousing, a video display device, memory such as volatile or non-volatilememory, processors such as microprocessors or digital signal processors,computational entities such as operating systems, drivers, graphicaluser interfaces, and applications programs, one or more interactiondevices (e.g., a touch pad, a touch screen, an antenna, etc.), and/orcontrol systems including feedback loops and control motors (e.g.,feedback for sensing position and/or velocity; control motors for movingand/or adjusting components and/or quantities). A data processing systemmay be implemented utilizing suitable commercially available components,such as those typically found in data computing/communication and/ornetwork computing/communication systems.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures may beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected”, or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

All publications, patents and patent applications cited herein areincorporated herein by reference. The foregoing specification has beendescribed in relation to certain embodiments thereof, and many detailshave been set forth for purposes of illustration, however, it will beapparent to those skilled in the art that the invention is susceptibleto additional embodiments and that certain of the details describedherein may be varied considerably without departing from the basicprinciples of the invention.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the following claims.

What is claimed is: 1.-60. (canceled)
 61. A method comprising: assessingone or more parameters associated with use of an inhaler by a subject;administering at least one active agent to the subject in response toassessing the one or more parameters associated with use of the inhaler;and administering at least one incentive agent to the subject incoordination with administering the at least one active agent.
 62. Themethod of claim 61, wherein the assessing one or more parametersassociated with use of an inhaler by a subject comprises: assessing oneor more parameters associated with respiration.
 63. The method of claim61, wherein the assessing one or more parameters associated with use ofan inhaler by a subject comprises: assessing one or more parametersassociated with inhalation. 64.-69. (canceled)
 70. The method of claim61, wherein the assessing one or more parameters associated with use ofan inhaler by a subject comprises: assessing a time period associatedwith any of an inhalation cycle, a breath hold cycle, or an exhalationcycle through the inhaler.
 71. The method of claim 61, wherein theassessing one or more parameters associated with use of an inhaler by asubject comprises: assessing if at least one value associated with arespiration parameter meets or exceeds a threshold value.
 72. The methodof claim 61, wherein the assessing one or more parameters associatedwith use of an inhaler by a subject comprises: assessing if at least onevalue associated with an inhalation parameter meets or exceeds athreshold value. 73.-74. (canceled)
 75. The method of claim 61, whereinthe assessing one or more parameters associated with use of an inhalerby a subject comprises: assessing one or more values associated with oneor more inhalation parameters and estimating a quantity of the at leastone active agent that will be effectively delivered in response to theone or more assessed values associated with the one or more inhalationparameters.
 76. (canceled)
 77. The method of claim 61, wherein theassessing one or more parameters associated with use of an inhaler by asubject comprises: assessing one or more values associated with one ormore inhalation parameters and estimating a quantity of the at least oneincentive agent that will be effectively delivered in response to theone or more assessed values associated with the one or more inhalationparameters. 78.-80. (canceled)
 81. The method of claim 61, wherein theadministering at least one active agent to the subject in response toassessing the one or more parameters associated with use of the inhalercomprises: administering the at least one active agent to the subjectwhen at least one value associated with a respiration parameter meets orexceeds a threshold value.
 82. The method of claim 61, wherein theadministering at least one active agent to the subject in response toassessing the one or more parameters associated with use of the inhalercomprises: administering the at least one active agent to the subjectwhen at least one value associated with an inhalation parameter meets orexceeds a threshold value. 83.-85. (canceled)
 86. The method of claim61, wherein the administering at least one incentive agent to thesubject in coordination with administering the at least one active agentcomprises: administering the at least one incentive agent after the atleast one active agent is administered. 87.-92. (canceled)
 93. Themethod of claim 61, wherein the administering at least one incentiveagent to the subject in coordination with administering the at least oneactive agent comprises: administering the at least one incentive agentin a quantity that is based on a quantity of the at least one activeagent that was delivered to the subject.
 94. (canceled)
 95. The methodof claim 61, wherein the administering at least one incentive agent tothe subject in coordination with administering the at least one activeagent comprises: administering the at least one incentive agent inresponse to assessing at least one value associated with a respirationparameter associated with use of the inhaler. 96.-99. (canceled) 100.The method of claim 61, wherein the administering at least one incentiveagent to the subject in coordination with administering the at least oneactive agent comprises: administering the at least one incentive agentto the subject when at least one value associated with a respirationparameter meets or exceeds a threshold value.
 101. The method of claim61, wherein the administering at least one incentive agent to thesubject in coordination with administering the at least one active agentcomprises: administering the at least one incentive agent to the subjectwhen at least one value associated with an inhalation parameter meets orexceeds a threshold value. 102.-104. (canceled)
 105. The method of claim61, further comprising: displaying a comparison of an assessed valueassociated with one or more respiration parameters with one or morelevels associated with the one or more respiration parameters.
 106. Themethod of claim 105, wherein the displaying a comparison of an assessedvalue associated with one or more respiration parameters with one ormore levels associated with the one or more respiration parameterscomprises: displaying a comparison of the assessed value associated withone or more respiration parameters to a range of levels associated withthe one or more respiration parameters and instructing the subject toachieve a value of the one or more respiration parameters that is withina range of threshold levels associated with the one or more respirationparameters. 107.-110. (canceled)
 111. The method of claim 61, furthercomprising: instructing the subject to achieve one or more valuesassociated with one or more respiration parameters.
 112. The method ofclaim 111, wherein the instructing the subject to achieve one or morevalues associated with one or more respiration parameters comprises:instructing the subject to achieve one or more values associated withone or more respiration parameters that meet or exceed one or morethreshold levels associated with the one or more respiration parameters.113.-116. (canceled)
 117. The method of claim 61, further comprising:accepting information associated with one or more parameters associatedwith the subject.
 118. The method of claim 117, wherein the acceptinginformation associated with one or more parameters associated with thesubject comprises: accepting information associated with one or morephysical parameters associated with the subject.
 119. (canceled) 120.The method of claim 117, wherein the accepting information associatedwith one or more parameters associated with the subject comprises:accepting information associated with one or more parameters associatedwith the subject and using the information in combination with one ormore delivery parameters to estimate a quantity of the active agent thatwill be effectively delivered to the subject.
 121. The method of claim61, further comprising: administering at least one additional activeagent to the subject. 122.-123. (canceled)
 124. The method of claim 61,further comprising: assessing one or more parameters associated withadministering the at least one active agent to the subject. 125.-127.(canceled)
 128. The method of claim 124, wherein the assessing one ormore parameters associated with administering the at least one activeagent to the subject comprises: assessing a quantity of the at least oneactive agent that was administered to the subject.
 129. The method ofclaim 124, wherein the assessing one or more parameters associated withadministering the at least one active agent to the subject comprises:assessing a quantity of the at least one active agent that wasadministered to the subject and then repeating the administration of theat least one active agent until a preselected quantity of the at leastone active agent is administered to the subject.
 130. The method ofclaim 61, further comprising: assessing one or more parametersassociated with administering the at least one incentive agent to thesubject. 131.-133. (canceled)
 134. The method of claim 130, wherein theassessing one or more parameters associated with administering the atleast one incentive agent to the subject comprises: assessing a quantityof the at least one active incentive that was administered to thesubject.
 135. The method of claim 130, wherein the assessing one or moreparameters associated with administering the at least one incentiveagent to the subject comprises: assessing a quantity of the at least oneincentive agent that was administered to the subject and then repeatingthe administration of the at least one incentive agent until apreselected quantity of the at least one incentive agent is administeredto the subject.
 136. The method of claim 124, further comprising:predicting one or more locations in the pulmonary tract of the subjectwhere the at least one active agent was delivered in response to the oneor more parameters associated with administration of the at least oneactive agent to the subject.
 137. (canceled)
 138. The method of claim130, further comprising: predicting one or more locations in thepulmonary tract of the subject where the at least one incentive agentwas delivered in response to the one or more parameters associated withadministration of the at least one incentive agent to the subject.139.-230. (canceled)
 231. A method comprising: assessing if at least onevalue associated with a respiration parameter meets or exceeds athreshold value associated with use of an inhaler by a subject;administering at least one active agent to the subject if the at leastone value meets or exceeds the threshold value; and administering atleast one incentive agent to the subject in coordination withadministering the at least one active agent.
 232. A method comprising:assessing one or more values associated with at least one respirationparameter associated with use of an inhaler by a subject; displaying acomparison of the one or more values with one or more threshold levelsassociated with the at least one respiration parameter; administering atleast one active agent to the subject in response to assessing the oneor more values; and administering at least one incentive agent to thesubject in coordination with administering the at least one activeagent.